Hazardous contaminant collection kit and rapid testing

ABSTRACT

Contamination detection systems, kits, and techniques are described for testing surfaces for the presence of hazardous contaminants, while minimizing user exposure to these contaminants. Even trace amounts of contaminants can be detected. A collection kit provides a swab that is simple to use, easy to hold and grip, allows the user to swab large areas of a surface, and keeps the user&#39;s hands away from the surface being tested. The kit also provides open and closed fluid transfer mechanism to transfer the collected fluid to a detection device while minimizing user exposure to hazardous contaminants in the collected fluid. Contamination detection kits can rapidly collect and detect hazardous drugs, including trace amounts of antineoplastic agents, in healthcare settings at the site of contamination.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/134,271, filed on Sep. 18, 2018, entitled “HAZARDOUS CONTAMINANTCOLLECTION KIT AND RAPID TESTING,” which claims the benefit of U.S.Provisional Patent Application No. 62/561,540, filed on Sep. 21, 2017,entitled “HAZARDOUS CONTAMINANT COLLECTION KIT AND RAPID TESTING,” thecontents of each of which are hereby incorporated by reference herein.

TECHNICAL FIELD

The systems and methods disclosed herein are directed to environmentalcontaminant testing, and, more particularly, to a test kit for detectingthe presence and/or quantity of antineoplastic agents.

BACKGROUND

Antineoplastic drugs are used to treat cancer, and are most often foundin a small molecule (like fluoruracil) or antibody format (likeRituximab). Detection of antineoplastic drugs is critical fordetermining if there is contamination/leakage in hospital/pharmacy areaswhere the drugs are used and/or dispensed.

The nature of antineoplastic agents make them harmful to healthy cellsand tissues as well as the cancerous cells. Precautions should be takento eliminate or reduce occupational exposure to antineoplastic agentsfor healthcare workers. Pharmacists who prepare these drugs and nurseswho may prepare and administer them are the two occupational groups whohave the highest potential exposure to antineoplastic agents.Additionally, physicians and operating room personnel may also beexposed through the treatment of patients. Hospital staff, such asshipping and receiving personnel, custodial workers, laundry workers andwaste handlers, all have the potential to be exposed to these drugsduring the course of their work. The increased use of antineoplasticagents in veterinary oncology also puts these workers at risk forexposure to these drugs.

SUMMARY

Existing approaches to detecting a hazardous drug contamination requirethe user to manually handle sample swabs directly by hand, press theswab material by hand when wiping a test surface, place the sampledswabs into a test tube/vial, and send the sample-impregnated swab to anoutside laboratory for testing. Directly handling a swab embedded withhazardous contamination is potentially dangerous for the test user.Further, these existing approaches use a small cotton swabs on a stickwhich covers very little surface area, requiring significant work andtime from the user. Further, the results can come back weeks (sometimesup to nine weeks) after when the test was taken, delaying anydecontamination response.

These and other problems are addressed in embodiments of the collectionand testing kit described herein that avoids further spread and exposureof contamination during the process of collecting the sample and quicklyprovides accurate test results at the site and time of testing. Thepresent technology provides a collection kit and detection system fortesting of various surfaces in healthcare settings for the presence ofantineoplastic agents while minimizing user exposure to these agents.The kit is capable of detecting even trace amounts of antineoplasticagents and of providing results quickly (including immediately aftercollection). Advantageously, testing and detection occur at the locationof the collection. The kit provides a swab that is simple to use, easyto hold and grip, allows for swabbing of large surfaces, and keeps theuser's hands away from the surface being tested. Beneficially, the kitalso provides a collection kit that is fluid-tight and provides forleak-free transfer of the collected fluid from the collection kit to thedetection system.

One suitable detection system includes an immunoassay device.Immunoassay devices play an important role in areas such as clinicalchemistry and have been made portable for use in the field. Immunoassaytechnology provides simple and relatively quick means for determiningthe presence of analytes in a subject sample. Analytes are substances ofinterest or clinical significance that may be present in biological ornon-biological fluids. The analytes can include antibodies, antigens,drugs, or hormones. The analyte of interest is generally detected byreaction with a capture agent, which yields a device more easilydetected and measured than the original analyte. Detection methods caninclude a change in absorbance, a change in color, change influorescence, change in luminescence, change in electrical potential ata surface, change in other optical properties, or any other easilymeasured physical property indicating the presence or absence of ananalyte in a sample.

Accordingly, one aspect relates to a hazardous contamination detectionsystem comprising a collection device comprising a buffer solutionconfigured to lift a hazardous contaminant from a test surface when thebuffer solution is applied to the test surface, an absorbent swabmaterial configured to absorb at least a portion of the buffer solutionand to contact the test surface to collect the hazardous contaminant, ahandle having a first end coupled to the absorbent swab material, asecond end spaced apart from the first end, and an elongate lengthextending therebetween, a fluid-tight container having an interiorvolume dimensioned to encase the handle and the absorbent swab materialand the buffer solution, the container having a nozzle including anorifice sized to provide controlled release of a volume of the buffersolution from the interior volume; and a detection device comprising anassay test strip positioned to receive the volume of the buffer solutionreleased from the container, the assay test strip comprising at leastone reaction zone configured to produce an optically-detectable changein appearance in the presence of the hazardous contaminant, and an imagesensor positioned to receive light reflected from the at least onereaction zone and configured to generate signals representing anintensity of the received light, and control electronics configured toanalyze the signals and determine the presence of the hazardouscontaminant in the at least one reaction zone.

Some embodiments of the system further comprise a demarcation guidespecifying an area of the test surface to be tested for contamination bythe hazardous contaminant. In some embodiments of the system, thecontrol electronics are configured to determine whether the hazardouscontaminant is in contact with the at least one reaction zone based atleast partly on the intensity of the signals and the area of the testsurface.

In some embodiments of the system, the assay test strip comprises asample receiving zone for receiving the volume of the buffer solutionreleased through the orifice of the nozzle; and a length of materialextending between the sample receiving zone and the at least onereaction zone and configured to wick at least the received buffersolution from the sample receiving zone to the at least one reactionzone.

In some embodiments of the system, the container comprises an open endhaving an aperture into the interior volume; and a releasable portion ofthe container including an attachment mechanism configured to releasablycouple to the container over the open end to provide a fluid-tight sealwith the interior volume of the container with the handle and theabsorbent swab material and the buffer solution sealed within theinterior volume, the nozzle, and a cap releasably coupled to the nozzle.

In some embodiments of the system, the handle has a first T-shaped crosssection, and wherein the interior volume of the container has a secondT-shaped cross section sized to receive the first T-shaped cross sectionof the handle.

In some embodiments of the system, at least a portion of the containeris flexible such that the interior volume can be compressed to expel thevolume of the buffer solution from the interior volume through theorifice of the nozzle.

In some embodiments of the system, the detection device comprises anetwork connection interface, and wherein the control electronics areconfigured to send data representing whether the hazardous contaminantis in contact with the at least one reaction zone to at least one remotecomputing device over a network via the network interface.

Another aspect relates to a hazardous contaminant collection devicecomprising a fluid-tight container having an interior volume; a buffersolution configured to lift a hazardous contaminant from a test surfacewhen applied to the test surface; an absorbent swab material configuredto absorb at least some of the buffer solution and to contact the testsurface to collect the hazardous contaminant; and a handle having afirst end coupled to the absorbent swab material, a second end spacedapart from the first end, and an elongate length extending therebetween;wherein the interior volume is dimensioned to contain the handle andabsorbent swab material and the at least some of the buffer solution,the container having a nozzle including an orifice sized to providecontrolled release of a volume of the buffer solution from the interiorvolume.

In some embodiments of the device, the container comprises an open endhaving an aperture into the interior volume; and a releasable portion ofthe container including an attachment mechanism configured to releasablycouple to the container over the open end to provide a fluid-tight sealwith the interior volume of the container with the handle and absorbentswab material and buffer solution sealed within the interior volume, thenozzle, and a cap releasably coupled to the nozzle. In some embodimentsof the device, the attachment mechanism comprises threading along aninterior surface of the releasable portion, and wherein the open end ofthe container comprises corresponding threading along an exteriorsurface of the open end.

In some embodiments of the device, the handle comprises a T-shaped crosssection defining a swab holding member having a flat first surface and asecond surface spaced apart from the first surface, and a handle portionextending away from the second surface. In some further embodiments, theabsorbent swab material comprises two layers of fabric coupled to thefirst surface of the flat swab holding member. In some furtherembodiments, a width of the absorbent swab material is greater than awidth of the flat first surface swab holding member. In some furtherembodiments, the absorbent swab material is coupled to the flat firstsurface of the swab holding member at opposing edges of the swabmaterial with a gap between a central portion of the absorbent swabmaterial and the flat first surface of the swab holding member. In somefurther embodiments, the interior volume of the container has a T-shapedcross section corresponding to the T-shaped cross section of the handle.

In some embodiments of the device, the nozzle comprises a channelleading to the orifice, wherein a cross-section of the channel is shapedto release the volume of the buffer fluid one drop at a time.

Another aspect relates to a method of testing a test surface for thepresence of a hazardous contaminant, the method comprising removing anabsorbent swab material coupled to an elongate handle from fluid-tightpackaging, the absorbent swab material pre-moistened with a first volumeof a buffer solution configured to lift the hazardous contaminant fromthe test surface, wherein the absorbent swab material is impregnatedwith the first volume of the buffer solution; wiping the test surfacewith the absorbent swab material to collect particles of the hazardouscontaminant from the test surface; inserting the absorbent swab materialinto an open end of a fluid-tight container, the fluid-tight containercomprising a well containing a second volume of the buffer solution anda cap to seal the well; sealing the fluid-tight container with the capto isolate the first and second volumes of the buffer solution withinthe fluid-tight container; agitating the fluid-tight container torelease at least some of the collected particles of the hazardouscontaminant into the buffer solution; opening a sealable orifice of thecap; transferring a third volume of the buffer solution from thefluid-tight container to an assay test strip through the sealableorifice; inserting the assay test strip into an assay reader device; andbased on an output of the assay reader device, identifying that thehazardous contaminant is present on the test surface.

Some embodiments of the method further comprise compressing an interiorvolume of the fluid-tight container to expel the third volume of thebuffer solution through the sealable orifice. Some embodiments of themethod further comprise sealing the sealable orifice after transferringthe third volume of the buffer solution.

BRIEF DESCRIPTION OF THE DRAWINGS

The disclosed aspects will hereinafter be described in conjunction withthe appended drawings, provided to illustrate and not to limit thedisclosed aspects, wherein like designations denote like elements.

FIG. 1A illustrates an example of an open system contaminant collectiondevice and open system detection device.

FIGS. 1B-1D illustrate various views of an example handle of thecollection device of FIG. 1A.

FIG. 1E illustrates an example collection container of the collectiondevice of FIG. 1A.

FIGS. 1F-1G illustrate various views of an example snap fit removabletop of the collection device of FIG. 1A.

FIG. 1H illustrates an example of the detents discussed with respect toFIGS. 1F-1G in a threaded embodiment of an example removable top.

FIGS. 1I through 1K illustrate various views of the handle of FIGS.1B-1D positioned within the collection container of FIG. 1E.

FIG. 1L illustrates a cross-sectional view of an example removable capof the collection device of FIG. 1A.

FIGS. 1M-1O illustrate various views and components of a collection kit.

FIG. 1P illustrates an example stability foot that can be used with thecollection container of FIG. 1E.

FIG. 2 illustrates another example of an open system contaminantcollection device.

FIGS. 3A and 3B illustrates example steps of a testing method using anopen system contaminant collection device.

FIG. 4 illustrates an example of a closed system contaminant collectiondevice.

FIGS. 5A-5D illustrate another example of a closed system contaminantcollection device and an example of a closed system detection device.

FIG. 6 illustrates example steps of a testing method using a closedsystem contaminant collection device.

FIGS. 7A through 7C illustrate an example testing device.

FIG. 8 depicts a high level schematic block diagram of an exampletesting device.

FIGS. 9A and 9B illustrate another example of a contaminant collectiondevice.

FIGS. 10A-10B illustrate another example of a contaminant collectiondevice.

FIG. 11 illustrates an example of a pivoting collection device swab.

FIG. 12 illustrates an example of a collection device including asqueegee.

FIGS. 13A and 13B illustrate another example of a collection deviceincluding a squeegee.

FIGS. 14A-14D illustrate various embodiments of a collection device witha built-in odometer.

FIG. 15 illustrates various examples of removal of fluid from acollection device swab.

FIG. 16 illustrates an example of a dissolvable swab.

FIG. 17 illustrates example steps for absorbing and removing fluid froma collection device swab.

FIG. 18 depicts a high level schematic block diagram of an examplenetworked test system environment.

FIG. 19 depicts a flow chart of an example process for test datageneration, analysis, and reporting.

DETAILED DESCRIPTION Introduction

Embodiments of the disclosure relate to systems and techniques fordetection of hazardous environmental contaminants, such as but notlimited to antineoplastic drugs used in the treatment of cancer, whileminimizing exposure of the test operator to the contaminants. A kit forsuch testing can include a collection device and a testing device.Throughout this disclosure, example systems, kits, and methods will bedescribed with reference to collection, testing, and detection ofantineoplastic agents, but it will be understood that the presenttechnology can be used to collect, test, and detect any particle,molecule, or analyte of interest.

A collection device can include a swab and a container for sealing theswab after collection of the antineoplastic agent. The swab can beconstructed from a special material having desired pickup efficiency andshedding efficiency for detecting trace amounts of antineoplasticagents, and is provided on a handle having sufficient length so that theuser can swab a surface without physically contacting the surface or theswab. A liquid, for example a buffer solution, can be provided withinthe container so that the user removes a pre-wetted swab to swipe thesurface in one implementation. In another implementation, the usersprays the surface with a liquid and collects this liquid with the swab.

The collection kit can further include a template, guide, orinstructions to delineate a specific dimensional area for testing. Inorder to obtain an accurate test result for contaminants that arehazardous even in trace amounts, a precise method of marking(demarcation) and then performing the sampling procedure (for example,to sample all of the demarcated area and only the demarked area) can bea very important step to ensure an accurate result. There are severalfactors that can be key to obtaining an accurate drug concentrationmeasurement given in the following formula:

$C = \frac{\propto {\star A \star \eta_{p} \star \eta_{e}}}{V_{b}}$

where C is the concentration, a is the contamination surface density(ng/ft{circumflex over ( )}2), A is the surface area swabbed and tested,η_(p) is the pick-up efficiency, li_(e) is the extraction from the swabdensity, and V_(b) is the fluid volume of the buffer solution used tohelp extract and carry the contamination to the test strip. A goal ofthe described testing can be to have a high concentration signal withlow variability. Excessive “noise” or variation in the variables maycause the test to either give false positive or false negative results.Test kits described herein can include mechanisms and/or instructions tousers to assist in reducing the variation of each term in the aboveconcentration equation.

After swabbing the surface, the user places the swab into the containerand the handle forms a liquid-tight seal when engaged with thecontainer. The handle can additionally lock to the container. Thecontainer can contain a buffer or diluent solution used as an agent tohelp remove the particles of interest embedded on the swab material intothe fluid of the container. The container advantageously prevents liquidfrom spilling and contaminating surfaces or users, but provides forcontrolled release of fluid to a detection system. Non-limiting examplesof such systems are referred to herein as “open system contaminantcollection devices” and “open system detection devices.” Someimplementations of the container can provide a fluid tight seal betweenthe sample vial and the test strip so that harmful fluids, drugs orvapors would be contained and not vented into the atmosphere andpossibly creating additional harm to the user. For example, thecontainer can be structured to attach and/or seal to the detectionsystem to provide a closed path for fluid transfer between the containerand the detection system. Non-limiting examples of such systems arereferred to herein as “closed system contaminant collection devices” and“closed system detection devices.”

The testing device can be an immunoassay reader, for example a lateralflow assay and reader device, with an interface that alerts the user tothe presence and/or degrees of contamination. Fluid can be released fromthe container onto a receiving zone of an assay test strip in someembodiments. The assay test strip can then be inserted into a reader toimage the indicators on the strip, analyze the image(s), determine alevel of contamination, and report the determined level of contaminationto the user. The reader can have more than one method of entering dataregarding the sample and can have various ways of saving, storing,displaying, uploading and alerting the appropriate personnel whenunacceptable levels of contamination are detected.

In one example, after detecting contamination in an initial test therecan be several possible next steps. A first option can be to remove thefluid tight connector and place the sample onto another more sensitivetest strip to determine an advanced level of detection. A second optioncan be to further dilute the sample to provide one or more additionallevels of dilution, and to then take a hot or high magnitude signal.Once measured the dilution amount can be taken into effect and an actualconcentration can be calculated based on the result and dilution amount.

The described swabs, buffer solutions, and test devices can beconfigured to pick up and detect trace amounts of antineoplastic agentsand/or chemotherapeutic drugs in some embodiments. It will beappreciated that the described systems can be adapted to collect anddetect quantities of other biohazardous chemicals, drugs, pathogens, orsubstances in other embodiments. Further, the disclosed systems can beused in forensic, industrial, and other settings.

Specific collection device embodiments illustrated and described hereinare characterized as having either an “open” or “closed” fluid transfermechanism. However, it will be appreciated that the illustrated fluidtransfer mechanisms are provided as non-limiting examples and that thedisclosed swabs, containers, and other collection device aspects of eachembodiment can, in various implementations, have either an open or aclosed fluid transfer mechanism.

Although the disclosed detection devices are typically described hereinwith reference to test strips and lateral flow assay reader devices, itwill be appreciated that the described hazardous contaminant detectionaspects described herein can be implemented in any suitable detectionsystem. For example, features described herein can be implemented inreader devices that analyze other types of assays, such as but notlimited to molecular assays, and provide a test result. Further, thecollected fluid can be transferred to a centrifuge, spectrometer,chemical assay, or other suitable test device to determine the presenceand/or concentration of one or more hazardous substances in the sample.

Drugs successfully treat many types of illnesses and injuries, butvirtually all drugs have side effects associated with their use. Not alladverse side effects classify as hazardous, however. In the presentdisclosure, the term “hazardous drugs” is used according to the meaningadopted by the American Society of Health-System Pharmacists (ASHP),which refers to a drug as hazardous if studies in animals or humans haveindicated that exposures to them have any one of four characteristics:genotoxicity; carcinogenicity; teratogenicity or fertility impairment;and serious organ damage or other toxic manifestation at low doses inexperimental animals or treated patients.

Although described in the example context of ascertaining theconcentration of hazardous drugs such as antineoplastic agents, it willbe appreciated that the disclosed test strips and reading techniques forextending competitive assay dynamic range can be used to detect thepresence and/or concentration of any analyte of interest. An analyte caninclude, for example, drugs (both hazardous and non-hazardous),antibodies, proteins, haptens, nucleic acids and amplicons.

Various embodiments will be described below in conjunction with thedrawings for purposes of illustration. It should be appreciated thatmany other implementations of the disclosed concepts are possible, andvarious advantages can be achieved with the disclosed implementations.

Overview of Example Open System Contaminant Collection Devices

A hazardous contamination detection kit can be used to identify andmeasure a specific area of surfaces to be tested and collect hazardousdrugs from those surfaces, for example in a pharmacy or in patientcare/nursing areas. This kit includes a collection device for samplingthe surfaces for possible contamination due to hazardous drugs. Aftersampling, fluid from the collection kit can be transferred to adetection device. The detection device can include a lateral flow assaytest strip that has been developed with the proper chemistry to detectthe desired contamination in the surface sample and an assay readerconfigured with instructions for imaging the assay, analyzing theimages, and determining a concentration level of the contaminant. Someembodiments of the collection device can be “open,” referring to thetransfer of fluid from the collection device to the detection devicewithout use of a liquid-tight transfer mechanism. For example, fluid canbe squeezed, poured, or dripped from the collection device onto an assaytest strip.

FIG. 1A illustrates an example of an open system contaminant collectiondevice 100 and an open system detection device 145. In this example,detection device 145 is a test strip 145 that includes a lateral flowassay. The collection device 100 can include a container 130, a handle120 with a swab 125, a removable top 115, and a removable cap 105. Insome examples, components of the collection device 100 are packagedseparately. For example, as will be described in greater detail below,the collection device 100 can include a first package and a secondpackage. The first package includes a buffer-filled container 130 insealed assembly with a removable top 115 and a removable cap 105. Thesecond package includes a handle 120 and a swab 125 that has beenpre-moistened with buffer fluid. The first package and the secondpackage can be individually sealed (in some cases, hermetically sealed)and can be provided to the user in a kit described in greater detailbelow.

The container 130 can be liquid-tight when the container 130, removabletop 115, and removable cap 105 are coupled together, and can containbuffer fluid. The removable top 115 and container 130 can includethreads for coupling as illustrated, or can include other suitablefluid-tight coupling structures, for example a snap fit. The container130 can include a stability foot 135 to keep it oriented upright whenpositioned on a flat surface. The cap 105 can be threaded or configuredto securely snap to the nozzle 110 of the removable top 115. Theremovable top 115 can be removed to provide access to the interior 140of the container 130, allowing a user to remove the handle 120 and swab125 from the container 130 and/or insert the handle 120 and swab 125into the container 130. The removable top 115 also allows a user to pourfluid from the container 130 onto a test surface. In other embodimentsin which the user uses the container 130 with a pre-moistened swab 125,the user may not pour any fluid from the container 130, therebymaintaining a known volume of fluid in the container 130. This featurecan be beneficial for accurate assessment of collected contaminantconcentration.

Components of the collection device 100 can be provided in any suitableconfiguration, depending on the needs of the user and the particularsample collection context. Components of the collection device 100 aredescribed herein with reference to an example kit in which apre-moistened swab material 125 and a handle 120 are provided in a firstsealed package, and a container 130 filled with buffer, a removable top115, and a removable cap 105 are provided in a second sealed package.Features of the example kit described herein advantageously limitexposure of the user to hazardous contaminants that are potentiallypresent on a test surface while also very precisely controlling factorsthat can affect the accuracy of detection results (and in particularconcentration measurements). It will be understood, however, that otherconfigurations are possible. Some configurations are suitable for samplecollection contexts where the analyte of interest is not a hazardouscontaminant. For example, swab material 125 may be provided within thebody of the container 130 and removed by the user prior to samplecollection. Buffer fluid may be included or not included within the bodyof the container 130. If buffer fluid is not provided within the body ofthe container 130, a user can add buffer to the container 130 prior tosample collection (before or after removing the swab material 125 fromthe body of the container 130). A handle 120 may be provided within thebody of the container 130 (for example, already coupled to thepre-moistened swab material 125), or it can be provided separately. Ifthe handle 120 is provided separately, the user can remove the swabmaterial 125 from the container 130 and attach it to the handle 120prior to sample collection.

Though not illustrated, the container 130 can contain a certain volumeof a buffer solution which will help lift the contamination from theswab material, keep the contaminate stable until it is ready to betransferred to the test strip 145, and provide a fluid suitable fortransferring the contaminant to the test strip and for cooperating withthe capillary action of the test strip to carry the contaminant toreaction zone(s) on the test strip. Possible buffer solutions aredescribed in more detail below.

The handle 120 can have a “T-shaped” cross section with the “top” of theT for use in securing the swab 125 and the “downwardly-extending”portion of the T used as a grip. The size of the handle 120 can beselected to minimize usage of material while still providing asufficient handle size to prevent contact between the hand of the userand the test surface. Some embodiments of a test kit can includeprotective gloves to provide a safeguard in addition to the handle 120for preventing contact between the test operator and the test surfaceand/or testing fluids. Even where a kit does not include gloves, userscan be instructed to use protective gloves during sampling and/orhandling of samples.

The swab 125 can be constructed from a special material having desiredpickup efficiency and shedding efficiency for detecting trace amounts ofcontaminants. Examples of swab materials are discussed in more detailbelow. Though shown in exploded view to illustrate the variouscomponents, the swab 125 can be coupled to the handle 120, therebyproviding the user with a mechanism to wipe a test surface withoutcontacting the surface and buffer fluid. The swab 125 and handle 120 canbe coupled, for example by ultrasonic welding to melt material of thehandle 120 into portions of the swab material, a clamping mechanismbuilt into the handle 120, by adhesive, or by any other suitableattachment mechanism. There may be one or multiple layers of swabmaterial provided on the handle 120. The swab material may be attachedto the handle 120 in a taut manner or may be loosely attached to thehandle 120. The swab 125 can include two layers of fabric. In oneadvantageous embodiment described in detail below, the swab is attachedto the handle 120 in a configuration where portions of the swab materialthat are not directly fastened to the handle 120 remain loose relativeto the handle 120.

The interior 140 of the container 130 can be shaped to substantiallyconform to the outer dimensions of the coupled handle 120 and swab 125in some embodiments so that the swab 125 and handle 120 can be securelyfitted within the interior 140. In the illustrated example, the interior140 has a “T-shaped” cross section that fits the profile of the handle120 and swab 125. This shape of the container can minimize the volume ofbuffer fluid needed to submerse a given portion of the handle in thebuffer fluid. It is also shaped to minimize the buffer fluid that canreside around the grip portion of the “T” of the handle, therebyensuring that most of the buffer fluid will be in the portion of theinterior 140 where the swab 125 is located. The shape of the interior140 is designed such that most of the fluid volume will be around theswab 125 and the container/handle design may not allow the swab 125 tobe compressed against the inside wall of the container 130, for exampleby providing additional space in the interior 140 around the swab 125.

In some embodiments, the length of the container interior 140 may bejust long enough for the handle 120 to be fully enclosed in the interior140, thus minimizing movement of the handle 120 when the container 130is inverted. As such, as the container 130 is inverted the buffer fluidmoves back and forth across the swab 125. In another embodiment, thecontainer 130 can be up to two times longer than the handle 120. Thisallows the handle 120 to slide back and forth with the buffer fluid asthe container 130 is inverted. This movement may aid in better flushingof the fluid through the swab 125.

In some embodiments the container 130 can contain a volume of buffersolution suitable for wetting a determined test area, for examplecorresponding to an area template or area instructions provided with thekit. A user can pour buffer solution from the container 130 onto thetest surface and then wipe the test surface with swab 125. In someembodiments the buffer solution can be provided in a separate container.After being applied to the test surface, the buffer solution can beabsorbed, together with any contaminants contained therein, by thematerial of the swab 125. As described herein, in some embodiments nobuffer solution may be poured from the container 130, and instead theswab material 125 can be pre-moistened with the buffer solution (or adilute version of the buffer solution).

In some embodiments the volume of buffer solution and swab 125 can beprovided together within the container 130 before use so that swab 125is pre-wetted with the volume sufficient for wetting the test area ofthe designated dimensions. In other embodiments the swab 125 can beprovided separately in a sealed package to maintain its pre-moistenedstate. A user can remove the swab 125 and handle 120 and wet the testsurface by wiping the swab 125 across the test surface, such as byapplying pressure to release the buffer solution from the pre-wettedswab 125. The user can in some embodiments perform additional wiping ofthe test surface with the swab 125 after release of the buffer solution,for example until most or all of the buffer solution is re-absorbed intothe swab 125.

After completing wiping of the test area of the test surface, the usercan insert the handle 120 and swab 125 into the container 130 and couplethe removable top 115 and removable cap 105 with the container 130 toenclose the buffer fluid within the fluid-tight interior 140. The usercan agitate the swab 125 within the sealed container 130 to shedcollected particles from the swab material into the buffer solution. Totransfer fluid from the interior 140 to the test strip 145, the user canremove the cap 105 and expel fluid through the nozzle 110, for exampleby inverting the container 130 and allowing fluid to drip through nozzle110. The nozzle 110 can be sized and shaped for controlled release of adrop (or other volume) at a time of fluid onto the test strip 145. Adrop is an approximated unit of measure of volume corresponding to theamount of liquid dispensed as one drop from a dropper or drip chambervia gravitational pull (sometimes aided by a positive pressure createdwithin the container holding the liquid). Though the precise volume ofany given drop depends upon factors such as the surface tension of theliquid of the drop, the strength of the gravitational field pulling onthe drop, and the device and technique used to produce the drop, it iscommonly considered to be a volume of 0.05 mL.

In some embodiments, the interior volume 140 of the container 130 can bereduced in order to dispense the fluid onto the test strip 145 fortesting. This can be accomplished in several ways. In a firstembodiment, the material of the container 130 is flexible enough toallow the user to squeeze the sides of the container 130 to expelcontrolled drops of fluid onto the test strip through the orifice of thenozzle 110. The flexibility can come from a combination of containerwall thickness and material modulus optimized so that the entirecontainer 130 can be squeezed. In a second embodiment, the container 130can have thin sections in the container wall, running either axially orradially, that give the container 130 hinge points where it can flexwhile the rest of the wall is thicker and stiffer. The user can thensqueeze the container 130 which flexes at the thin hinge points thusreducing the interior volume forcing the fluid out through the driporifice without the entire wall being thin enough to flex. In a thirdembodiment, a portion of the cap 115 that contains the nozzle 110 driporifice is flexible to allow a change in volume while leaving thecontainer inflexible. The whole cap 115 or part of the cap may be madeflexible. The flexible portion may only be a single section or spot thatallows enough deflection to push a drop of fluid out when compressed ordeflected. Other configurations to expel a drop or other volume of fluidfrom the container 130 through the nozzle 110 in a controlled manner arepossible. In other embodiments, the container 130 may not requiresqueezing to dispense fluid from the container, and may dispense dropsof fluid upon inversion with cap 105 removed.

Test strip 145 can include a sample receiving zone 150 and reaction zone155. The user can transfer the fluid from container 130 to samplereceiving zone 150, and the test strip can wick the fluid and anycontaminants contained therein along the length of the test strip toand/or through the reaction zone 155. Reaction zone 155 can include oneor more analyte binding regions. As illustrated, the actual capillarytest strip can be housed within a cartridge with windows correspondingto the locations of the sample receiving zone 150 and reaction zone 155.

FIG. 1B illustrates a perspective view of an example handle 120 of thecollection device 100 of FIG. 1A. The handle 120 includes a base portion122 for securing swab material (not illustrated in FIG. 1B) and a gripportion 121 extending from the base portion 122. The grip portion 121and base portion 122 can be formed as a unitary structure, for examplevia injection molded plastic. The base portion 122 includes a firstportion 122A adapted to fasten to the swab material and a second portion122B adapted to support the swab material 125 as it contacts the testsurface. The first portion 122A and the second portion 122B can be onopposite sides of the base portion 122 as in the illustratedimplementation, but other configurations are possible.

As illustrated, the grip portion 121 extends perpendicularly from thecenter of one face of the base portion 122. The grip portion 121 canextend away from the base at other angles and/or from other locationsalong the width of the base portion 122 in other embodiments. The gripportion 121 can have a height sufficient to keep the fingers of a useraway from a surface in contact with the swab material secured to thebase 122, for example 0.25 inches or more, or 0.5 inches or more, invarious embodiments. In one non-limiting example, the height of the gripportion 121 is about 0.525 inches. The grip portion 121 can extend alongthe full length of the base portion 122 as illustrated, or can extendalong just a portion of the length of the base portion 122. In someembodiments the width of the base portion can also assist in shieldingthe fingers of the user from the test surface, and the width can be forexample 0.25 inches or more, or 0.5 inches or more, in variousembodiments. In one non-limiting example, the width of the base portion122 is about 0.55 inches. Embodiments of the base portion 122 with awidth of about 0.55 inches can include about 0.2 inches clearance oneach side of the grip portion 121 for the user's fingers to grip thehandle 120. This can shield the user's fingers from the test surfacebelow the base portion 122 during use of the handle 120, and can, forexample, act as a stop to prevent the user's fingers from contacting thetest surface. These example dimensions are illustrated in FIG. 1C forillustrative purposes only; other dimensions are possible and the handle120 may not be drawn to scale. In some embodiments, the base portion 122extends at least 0.1 inches beyond the user's finger on either side ofthe handle 120 when the user grips the handle 120.

The base portion 122 has a number of securing features 123 extendingalong at least a portion of the length of the base portion 122 from thesame surface as the grip portion 121. As depicted, the securing features123 can be a number of triangular prisms, for example two rows eachhaving three axially-aligned triangular prisms. Other shapes, numbers,and configurations of the securing features are possible in otherembodiments. FIGS. 1B and 1C depict the securing features 123 prior toattachment of the swab material. The swab material can be attached tothese features 123 via ultrasonic welding in some embodiments. Forexample, the swab material can be positioned with a center portion alonga face of the base portion 122 opposing the face with the securingfeatures 123 with opposing edges of the swab material wrapped around thesides of the base portion 122 and positioned over the securing features.Ultrasonic energy can be applied to the securing features 123, causingthe material of the features to melt or liquefy and flow into the fabricof the swab material. When the energy is removed the melted materialsolidifies, providing a mechanical attachment between the handle 120 andthe swab material. Other mechanisms to attach the swab material to thebase portion 122 are possible. In other embodiments the securingfeatures 123 can be omitted and other mechanical fasteners (e.g.,pins/screws) and/or adhesive can be used in place of the securingfeatures.

FIG. 1C depicts a cross-sectional view of the handle 120 having swabmaterial 125 secured to the securing features 123 as described above,and FIG. 1D depicts a perspective view of the handle 120 and securedswab material 125. As depicted in FIG. 1D, in this non-limiting examplethe swab material 125 is formed from a material, for example wovenpolyester, folded or stacked into two layers 125A, 125B. The opposingedges of this dual-layer fabric are positioned over the securingfeatures 123 (shown in cross-section FIG. 1C but obscured by the fabricin FIG. 1D) with the melted material of the securing features 123solidified within the open space of the weave, thereby securing some ofthe woven fibers of the swab material 125 within the solidified securingfeature material. Although FIG. 1C depicts the solidified securingfeatures 123 in their original triangular configuration, due to themelting and solidification process other shapes are possible. Portionsof the swab material 125 can be secured to first portion 122A of thebase portion 122 of the handle 120 such that other portions of the swabmaterial proximal to the second portion 122B of the base portion 122remain loose relative to the handle 120. The swab material is configuredto be loose enough to form a gap 126 between the surface 127A of theswab material 125 and the surface 127B of the second portion 122B of thebase portion 122. The gap 126 can enable the swab material 125 to beagitated by buffer solution to extract collected contaminants from theswab material 125, and can be between 0.25 inches and 0.75 inches insome embodiments. The swab material 125 may be longer than the base 122of the handle such that around 0.25 inches extends beyond the edges ofthe base 122. Other embodiments can use greater or fewer than two layersfor the swab material 125, and can use separate pieces of fabric (forexample, layered and then cut and sealed along the opposing edges thatare wrapped over the securing features) or a single length of foldedmaterial.

FIG. 1E illustrates an example collection container 130 of thecollection device of FIG. 1A. The collection container 130 has acircular upper rim 141 and a well wall 142 extending from the rim 141and forming a well 140. The collection container 130 can be formed froman injection-molded plastic in some embodiments. The rim 141 can includea recessed portion between ridges for securing a retaining ring of asnap top as in the illustrated embodiment, with the ridges used tosecure the snap top in place. In another embodiment, the rim 141 can bethreaded in a corresponding manner with a threaded top. The well 140 canbe formed with a T-shaped cross-section as illustrated to substantiallymatch the shape of the handle 120. The well wall 142 can have uniform orsubstantially uniform (e.g., within acceptable manufacturing tolerances)walls in some embodiments such that the outer shape of the container 130matches the cross-section of the well 140.

FIG. 1F illustrates a perspective view of the top of an exampleremovable top 115 of the collection device of FIG. 1A, and FIG. 1Gillustrates a cross-sectional side view of the removable top 115. Theillustrated removable top 115 is configured to snap or press-fit ontothe ridges of the upper rim 141 of the container 130. Other embodimentscan include a threaded or other suitable connection rather than a snapor press-fit connection. For instance, the example collection device 100described below with reference to FIG. 1H includes a threaded removabletop 115 configured to engage a threaded container 130. Embodiments ofcollection devices 100 according to the present disclosure canadvantageously create a fluid-tight seal between the removable top 115and the container 130 with minimal user force and with the fewest numberof components, thereby reducing risk that the user will not create afluid-tight seal when the user engages the removable top 115 to thecontainer 130.

The removable top 115 includes a frustoconical body with, a threadednozzle 110 at the tip of the frustoconical body including fluid outletchannel 116, a tab 113 to assist a user in removing the top 115, andinterior features including a cylindrical wall 117 and one or moredetent(s) 118. The nozzle 110 need not be threaded and may interact witha removable cap 105 via a snap or press-fit connection, or any othersuitable mechanism. The removable top includes a hinge 114 attaching aretaining ring 111 to the frustoconical body. Some embodiments can omitthe tab 113, the retaining ring 111, and the hinge 114.

On the underside of the frustoconical body is the cylindrical wall 117spaced apart from the detent(s) 118. The detent(s) 118 can include oneor more protrusions extending from the inner rim of the top 115 towardsthe wall 117 or can be formed as a continuous annular feature. Thecylindrical wall 117 includes a protrusion 119 that faces the detent(s)118. Similar to the detent(s) 118, the protrusion 119 can include one ormore protrusions or a continuous annular feature. The detent(s) 118 andcylindrical wall 117 are configured to secure the removable top 115 tothe upper rim 141 of the container by positioning the upper rim 141 ofthe container 130 between the detent(s) 118 and the protrusion 119. Forexample, the protrusion 119 can be pressed into the inside of the mouthof the container opposite the rim 141 that extends around the exteriorof the mouth of the container. This can seal the top 115 to thecontainer 130. In one non-limiting example, the hoop strength of thecylindrical wall 117 and protrusion 119 combined with the deflection ofthe cylindrical wall 117 provides a normal force that seals theprotrusion 119 to the inside wall of the container 130. The detent(s)118 can secure to corresponding detents in the upper rim 141 of thecontainer 130 to securely hold the top 115 onto the container 130, aswell as to provide tactile and/or audible “click” feedback to the userto indicate that the top 115 is securely in place. Similar detents canbe provided in a threaded embodiment of the top 115. Securing the top115 to the container 130 beneficially prevents spillage of the bufferfluid, which potentially contains hazardous materials after the handle120 is inserted into the container 130. Beneficially, embodiments ofcollection devices 100 described herein that include the wall 117,protrusion 119, and detent 118 can mitigate spillage of liquids fromwithin the well 140 of the container 130 without the use of a separatesealing member or gasket. Accordingly, the collection devices 100according to the present disclosure advantageously limit the number oftotal number of individual, separate components while also providing afluid-tight seal, thereby limiting the risk of failure of components,the risk that components will not be aligned properly when assembled,and the risk that components will not operate as intended to create afluid-tight seal. As one example, conventional collection devices thatuse sealing gaskets to create fluid-tight seals may fail if the gasketis cracked, torn, misaligned, or has even a minute defect or flaw due tochemical breakdown (which can occur with age) or faulty manufacturing.Embodiments of the collection device 100 advantageously mitigate theseand other risks to minimize the potential that a user will be exposed tohazardous materials, including highly toxic contaminants that areextremely hazardous to human health even in minute amounts.

As shown in FIG. 1G, the inner aperture 116A of the channel 116 can besmaller than the outer aperture 116B of the channel 116. Accordingly,the channel 116 in this non-limiting embodiment is a tapered channelwithin the nozzle 110. The taper of the channel 116 can advantageouslypromote consistent drop sizes (consistent volume, consistent shape,etc.) for dripping fluid out of the well 140 through the nozzle 110, forexample onto a test strip as shown in FIG. 1A.

FIG. 1H illustrates an example collection device 100 in which theremovable top 115 and the container 130 are coupled using a threadedengagement rather than a snap- or press-fit engagement. FIG. 1H alsoillustrates an example of the detents discussed with respect to FIGS.1F-1G in a threaded embodiment of the removable top 115. The removabletop 115 includes threads 112A positioned along the internal surface ofits lower rim. The container 130 includes corresponding threads 112Bpositioned along the external surface of its upper rim. The threads112A, 112B are configured to engage and mechanically mate with oneanother. The threads 112A of the removable top 115 have at least one gap149A where the axial spiral of the threads 112A are interrupted and anegative space is formed. The container 130 includes a correspondingnumber of bump(s) 149B that align with the position of the gap 149A whenthe top 115 is screwed onto the container 130. The gap 149A and the bump149B thus function as the detent described above to provide tactileand/or audible feedback to the user when the top 115 is correctlyaligned with and fully threaded onto the container 130. In one example,the top 115 is provided with two gaps 149A on opposing sides of thethreads 112A and the container 130 is provided with two correspondingbumps 149B. Thus, in some embodiments the described detent can be acombination of one or more gaps in the top threads that correspond withone or more bumps on the container to cause a snap or click when the topis fully screwed on.

FIG. 1I illustrates a cutaway side view of the collection container 130of FIG. 1E with the handle 120 of FIGS. 1B-1D positioned within thecollection container 130. FIG. 1I shows the rim 141 forming acylindrical opening leading into the T-shaped well 140.

The handle 120 is depicted without the swab material attached in FIG.1I. As illustrated, in this non-limiting embodiment the length L_(H) ofthe handle 120 is less than the length L_(R) of the interior of the well140 that extends from the highest point of the well W_(HP) to the lowestpoint of the well W_(LP). In some embodiments, the difference betweenthe length L_(H) of the handle 120 and the length L_(R) of the interiorof the well 140 can be at least ⅛th inches, and preferably between ⅛thinches and ¼ inches. In one example implementation, the length L_(H) ofthe handle 120 is 2 inches and the length L_(R) of the interior of thewell 140 is 2.25 inches. Providing a well with a greater length than thehandle advantageously increases the amount of contaminant flushed fromthe surface of the swab material, for example when the user invertscontainer 130 and buffer fluid in the container 130 washes back andforth across the swab material to remove any picked-up contaminants.While the user inverts the container the handle 120 slides back andforth within the well 140 to provide for better washing of the fabricthan in implementations having the same length for the handle and well.

FIG. 1J illustrates a top view of the handle 120 positioned within thewell 140, and depicts a representation of the swab material 125 (shownin two layers 125A, 125B) secured to the handle. As illustrated, theswab material 125 can be secured loosely to the base portion 122 of thehandle 120 such that there can be a gap between the inner layer 125B ofswab material and the surface of the base portion 122 facing the innerlayer 125B. For example, the swab material 125 can be between 0.050inches and 0.220 inches longer than the width of the handle. Thisresults in portions of the fabric remaining loose relative to thesurface 127B of the handle 120 and forming a gap 126 between the swabmaterial and the handle 120 in which buffer fluid can freely flow,thereby allowing fluid to efficiently pass through and agitate theportion of the swab material that made direct contact with the testsurface. The layers 125A, 125B can have the same or different widthsacross the width of the base portion 122.

The well 140 includes a first portion 140A sized to receive the baseportion 122 of the handle 120 with the swab material 125, and the wellfurther includes a second portion 140B sized to receive the grip portion121 of the handle 120. In examples such as that illustrated in FIG. 1J,the second portion 140B is sized to snugly receive the grip portion 121of the handle 120 (in other words, there is very little space betweenthe second portion 140B and the grip portion 121 such that theirsurfaces are in constant contact or near constant contact). Asillustrated, the second portion 140B has a substantially similarcross-section to the grip portion 121, where “substantially” refers to across-section of the second portion 140B being slightly larger to allowthe grip portion 121 to slide into the second portion 140B. Thecross-section of the first portion 140A corresponds to thecross-sectional area occupied by the base portion 122 of the handle 120with the swab material 125 with a small gap to allow the swab material125 to flow freely in the buffer solution in the well 140. Beneficially,providing the second portion 140B to have a similar interior volume tothe volume occupied by the grip portion 121 causes the grip portion 121to push most if not substantially all fluid in the well 140 out of thesecond portion 140B and into the first portion 140A when the handle 120is inserted into the container. This can reduce the amount of buffersolution required to be placed in the well 140 in order to wash thedesired amount of contaminants from the swab material 125, whichbeneficially increases the concentration of the contaminants in thesolution compared to other embodiments that require greater amounts ofbuffer solution. The first portion 140A can be sized to substantiallymatch the shape of the handle's base portion 122 with swab materialattached, though the first portion 140A can (as illustrated) be slightlylarger in order to facilitate agitation of the loose swab materialduring inversion of the container 130.

As such, the complementary shapes of the well 140 and handle 120(including swab material 125) provide at least the following benefits:(1) minimizing unneeded “dead space” (e.g., space not occupied by handle120 or swab material 125) inside the well 140 when the handle isinserted into the well 140, thus reducing the volume of buffer solutionneeded to extract contaminants from the swab material; and (2)maximizing concentration of the contaminant in the solution by promotingagitation of the material to extract the contaminant. Regarding unneeded“dead space” and the first portion 140A, a small amount of space isbeneficial around the swab material 125 in order to allow the swabmaterial to flow within the buffer solution and be agitated byturbulence during container inversions, thereby releasing the maximumquantity of collected contaminant from the swab material 125 into thesolution. However, providing too much dead space creates a requirementfor a greater amount of buffer solution to contact the swab material125, thereby reducing the concentration of collected contaminant in thebuffer solution. The complementary shapes of the well 140 and handle 120thus enable accurate detection of even minute quantities of collectedcontaminants by maximizing both contaminant shedding from the swabmaterial 125 and contaminant concentration in the buffer solution.

Although the sides of the grip portion 121 and second portion 140B ofthe well 140 are depicted as being straight, in other embodiments thesides of the grip portion 121 and the inner walls of the second portion140B of the well 140 can be “keyed,” that is, have correspondingfeatures (e.g., curved or angled portions). Embodiments having a keyedgrip portion 121 and second portion 140B beneficially can maintain thepositioning of the grip portion 121 fully within the second portion 140Brather than allowing the base portion 122 to slide toward the far sideof the first portion 140A of the well.

FIG. 1K illustrates example dimensions of portions of the handle 120,well 140, and swab material 125 in order to illustrate and not limit thedescribed complementary shapes of the handle and the well. In oneembodiment, the base portion 122 of the handle 120 has a width HB_(W) ofabout 0.55 inches, the swab material 125 has a thickness SM_(T) of about0.06 inches and thus the combined width of the handle (between the baseportion 122 and the four layers of swab material 125) is about 0.67inches. The greatest width C_(W) of the first portion 140A of thecontainer well is about 0.73 inches at a highest point W_(HP) (see FIG.1I) along the height of the well. The width of the well can taper alongthe height of the well to be about 0.67-0.69 inches at a lowest pointW_(LP) (see FIG. 1I) of the well. Thus, the width C_(W) of the firstportion 140A can match or substantially match (e.g., at a smallest pointalong a tapered width) the total width of the handle base 122 and layersof swab material 125. In this embodiment, the platform of the baseportion 122 of the handle 120 has a thickness HB_(T) (with thisthickness measured along the height of the handle) of about 0.1 inchesand the two layers of swab material 125 positioned between the base 122and the opposing wall of the well 140 have the thickness SM_(T) of about0.06 inches. The greatest depth C_(D) of the first portion 140A of thecontainer well is about 0.338 inches, which gives the 0.06 inches ofswab material 125 about 0.238 inches (at the deepest point of the firstportion 140A) through which the material can move loosely and freelyduring agitation. Buffer fluid can flow freely through this portion ofthe material, passing back and forth between the surface of the materialthat made direct contact with the test surface and the opposing surfaceof the material, thereby releasing analytes of interest captured in thematerial into the buffer fluid with greater efficiency and in greaternumbers. As described above, in some embodiments the handle 120 and well140 can be “keyed” by providing corresponding features along thecross-section of the second portion 140B of the well 140 and the gripportion 121. This keying can ensure that the relative positioning of thehandle 120 along the depth of the well is maintained as shown with thegrip portion 121 positioned fully back into the second portion 140B,causing all or substantially all fluid to be forced out of the secondportion 140B of the well 140 by the grip portion 121 and maintaining thedistance of 0.238 inches (at the deepest point) through which the bufferfluid can flow freely through the swab material 125.

FIG. 1L illustrates a cross-sectional view of an example removable cap105 of the collection device of FIG. 1A secured onto the threaded nozzle110 of the top 115. The cap 105 can include grip features 103 tofacilitate a user turning the cap. As described above, the cap 105 neednot be threaded and can interact with the top 115 using other suitablemechanisms, such as but not limited to a snap or press-fit mechanism.The removable cap 105 includes a cavity 106 lined with threads 104 forscrewing onto the threaded nozzle 110 of the top 115. The cap 105 alsoincludes a protrusion 101 extending into the cavity 106. The protrusion101 is configured to plug the orifice 116 of the nozzle 110 of the top115 with the upper wall 107 of the cavity sealing against the topsurface of the nozzle 110. The protrusion 101 can be tapered to matchthe tapered contours of the channel 116. The protrusion 101 has at itslowest region (e.g., the region positioned furthest within the channel116 when the cap 105 is screwed onto the nozzle 110) a post 102 thatextends into the inner aperture 116A of the channel 116. This shaping ofthe cap 105 can serve to minimize any “dead space” in the channel 116 ofthe top 115 that could collect buffer solution in a manner thatinterferes with test result accuracy. For example, without the describedfeatures of the cap 105, buffer solution could collect within thechannel 116 of the top 115 and stay in the channel 116 as the swabmaterial 120 is agitated to release collected contaminants. This“trapped” buffer would be the first liquid to drip out of the container130 due to its positioning in the channel 116, but it may not have mixedwith the rest of the solution during agitation and thus would notcontain any (or a great quantity of) collected contaminants. Additionalfeatures of the cap 105 according to the present disclosureadvantageously avoid these potential issues. For example, the protrusion101 of the cap 105 has an exterior shape that corresponds to the innershape of the channel 116, thereby preventing buffer solution fromaccumulating within the channel 116 of the top 115. In one example, theprotrusion 101 and the channel 116 have a first segment 101A angled ataround 3.7° relative to a central axis A of the channel 116, with thefirst segment 101A forming a primary/largest sealing surface between theprotrusion 101 and the channel 116. The first segment 101A can befollowed by a second segment 101B angled at around 60° relative to thecentral axis A of the channel 116, where this second segment 101B actsas a stop to indicate to the user that the cap 105 has been fullythreaded onto the nozzle 110. One or more detents may be included tofacilitate providing such an indication to the user. The post 102 issized to fill the inner aperture 116A of the top 115 withoutinterference, and the post 102 and engaged surfaces of the secondsegment 101B cooperate to prevent fluid from entering the channel 116when the cap 105 is fully screwed onto the nozzle 110 of the top 115.

FIG. 1M illustrates an example set 160 of the components of FIGS. 1A-1Lthat can be included in a collection device kit. The set 160 includesthe container 130, top 115, cap 105, and handle 120 (including swabmaterial). The kit can be packaged such that the container 130 isprovided with a specified volume of buffer solution in the well and thensealed with the top 115 and the cap 105. The handle 120 can be packagedseparately within the kit, and can be pre-moistened with a dilutedversion of the buffer solution within the container 130. FIG. 1L1Mdepicts a threaded version of the container 130 and top 115.

FIG. 1N illustrates an example collection kit 170 including the set 160of components of FIG. 1M. The collection kit 170 includes a firstcontainer 171 that houses assembled container 130, top 115, and cap 105(containing a volume of buffer solution as described herein) and alsohouses a second container 173. The first container 171 can be aheat-sealed polymer pouch with tear slits 172 in some embodiments. Thesecond container 173 is a sealed enclosure housing the assembled andpre-moistened swab material 125 and handle 120. The second container 173can be a heat-sealed polymer pouch with tear slits 174 in someembodiments. For example, the assembled swab material 125 and handle 120can be placed on a portion of the film that forms the second container173, sprayed or otherwise provided with a dilute version of the bufferfluid in the container 130, and then the second container 173 can besealed around the moistened swab. The second container 173 can be ametalized polymer that includes a foil or metal in the material formingthe pouch of the second container 173. Metalized polymer containers canadvantageously maintain and preserve fluid, such as fluid that has beenprovided to the swab material 125, during shipping and storage.

In order to use the set 160 of components to perform wiping of a testsurface as described herein, the user can open the first container 171of the collection kit 170 and remove the container 130 with the top 115and cap 105 attached and with the reagent and buffer solution alreadywithin the well of the container 130. The user can remove the secondpackage 173 with the separately packaged handle 120 with the swabmaterial pre-attached and pre-moistened with the dilute version of thefluid in the container 130, open the second package 173, and wipe thetest surface with the pre-moistened swab material. The user can removethe top 115 from the container 130 to provide access to the well 140.After completing the wiping of the test surface, the user can slide thehandle 120 into the well 140 of the container 130, close the top 115onto the container 130, and invert the container 130 (e.g., flip it 180degrees) a number of times, for example 5 or more times. As discussedabove, inverting the container 130 washes the swab material with thebuffer solution and extracts any contaminants picked up from the testsurface. After completing the recommended number of inversions ofcontainer 130, the user can remove the cap 105 and drip the buffersolution (and any contained contaminant particles) onto a test stripthrough the orifice 116.

FIG. 1O illustrates an example package 180 that includes a number ofcollection kits 170. The package 180 includes two shelf boxes 181A, 182Bthat each can house, for example, ten collection kits 170. The shelfboxes 181A, 182B are provided within a larger shipping container 182.Optionally, the shipping container 182 can also include templates todemarcate the test surface and assist the user during sample collection,assay test strips, and/or assay reader devices as described herein.

FIG. 1P illustrates an example stability foot 135 that can be used withthe collection container of FIG. 1E. In FIG. 1A, the stability foot 135is shown as integrated into the collection container 130. However, inother embodiments the collection container 130 can be formed separatelyfrom the stability foot 135, as shown in FIG. 1P. The stability foot 135can include a T-shaped wall 136A defining a T-shaped aperture 136B sizedto snugly receive the bottom of the container 130, with the T-shapedwall 136A extending upwardly from a wider base portion 136C. The baseportion 136C can contact a surface on which the container 130 is set andprovide stability so that the container 130 is not as easily tipped. Thebottom of the container 130 can be press fit into the aperture 136B, orit can have snap features such as a bump on the container that fits intoa recess on the interior of the T-shaped wall 136A (or vice-versa) toprovide the user with tactile and/or audible feedback of the container130 being positioned correctly within the stability foot 135.

FIG. 2 illustrates perspective views of another example of an opensystem contaminant collection device, with two such devices 200A, 200Bshown. Each device 200A, 200B can include a swab 230 and a container 220for sealing the swab 230 after collection of contaminant particles.

The swab 230 can be constructed from a material having desired pickupefficiency and shedding efficiency for detecting trace amounts ofcontaminants, for example antineoplastic agents. Examples of swabmaterials are discussed in more detail below. The swab 230 is providedon a handle 225 having sufficient length so that the user can swab asurface without physically contacting the surface or the swab 230. Theswab 230 can be pivotably coupled to the handle 225 in some embodiments.The handle 225 can be coupled to or part of a cap 210 in someembodiments. As such, cap 210 can include a portion 205 extending fromthe body of the cap 210 for grasping by a user.

A liquid, for example a buffer solution, can be provided within thecontainer 220 so that the user removes a pre-wetted swab to wipe thesurface (and optionally pours additional fluid onto the surface from thecontainer 220) in one implementation. In another implementation, theuser can spray the surface with a liquid and collects this liquid withthe swab.

After swabbing the surface, the user places the swab 230 into thecontainer 220 and the cap 210 forms a liquid-tight seal when engagedwith the container 220. The cap 210 can additionally lock to thecontainer. As illustrated, cap 210 can include one or more tabs 215 thatsecurely couple the cap 210 to the container 220 to provide afluid-tight enclosure within the container 220. The tabs 215 canreleasably engage corresponding features of the container 220 to bothprovide the fluid-tight seal and allow for removal and use as the handleof the swab 230. A base 235 of the container 220 can be shaped to allowthe container 220 to stand upright on a surface, further preventingfluid spillage from container 220. The lower interior portion of thecontainer 220 can include steps 245, wedges, or other structures alongits interior to squeeze fluid from the swab 230 when inserted fully intothe container 220. Thus, the length of handle 225 can be selected toforce swab 230 onto the steps 245 when the cap 210 is coupled to thecontainer 220.

The container 220 advantageously prevents liquid from spilling andcontaminating surfaces or users, but provides for controlled release offluid to a detection system. The detection system can be an immunoassay,for example a lateral flow assay, with an interface that alerts the userto the presence and/or degrees of contamination. Controlled release ofthe fluid can be provided through a release mechanism, such as valve240. Valve 240 can be a one-way valve in some embodiments. In someembodiments, the body of the container 220 can be flexible to allow auser to squeeze fluid through the valve 240. In some embodiments, thebase 235 of container 220 can be flexible to allow a user to squeeze thevalve 240 open to allow fluid to drop through while keeping the hands ofthe user away from the fluid. In other embodiments the valve 240 can beincorporated into a coupling mechanism for coupling to a closed systemdetection device and the collection device 200A, 200B can be a closedsystem contaminant collection device as discussed in more detail below.

In some embodiments, a user can shake or otherwise agitate thecollection devices shown in FIGS. 1A-2 prior to transferring the fluidto a detection device to release collected contaminants from the swab125, 230 into the buffer fluid in the container. For example, thecontainer can be inverted a number of times to allow the buffer fluid toflow back and forth across the material of the swab. The buffer fluidcan have properties that assist in releasing collected contaminants fromthe swab material in some implementations, as discussed in more detailbelow. As such, the flow of the buffer fluid can extract thecontamination from the material of the swab and mix it into ahomogeneous solution for testing.

FIG. 3A illustrates example steps of a testing method 300A using an opensystem contaminant collection device, such as but not limited to thoseshown in FIGS. 1A-2 . One, some, or all of the depicted blocks of FIG.3A can be printed as graphical user interface instructions on thepackaging of an assay and/or collection kit, for example the packagingshown in FIGS. 1N and 1O, or can be presented on a display screen of anassay reader device, a test area terminal, or a personal computingdevice of the user.

At block 340, the user can identify a sample location and gather acollection kit, assay cartridges, and a template. The collection kit canbe the kit 170 described above and can include container 130, top 115,and cap 105 assembled and containing buffer solution, and can include asealed package with handle 120 and pre-moistened swab material 125. Thecollection kit can include a swab attached to a handle and a collectioncontainer. In some examples, the swab is pre-wetted with buffer solutionand packaged together with the handle in a first sealed pouch and thecollection container is packaged in a second sealed pouch. The assaycartridge may include an assay device housed inside a cartridge having awindow or port aligned with a sample receiving zone of the assay device.In one implementation, the assay device is a test strip, for example butnot limited to a lateral flow assay test strip. Also at block 340 theuser can put on clean gloves prior to each sample collection and/oropening of the collection kit, both to protect the user from potentialcontamination on the surface and to protect the collected sample fromcontamination on the user's hands.

At block 345, the user can establish a test area on the test surface.For example, the user can place a template (physical or augmentedreality) over the intended location to clearly demarcate the area thatwill be swabbed. Also at block 345 the user can open the collection kitpackaging, including opening the separately-packaged swab and handle.The test area may be one square foot in some embodiments, for exampledemarcated as a 12 inches by 12 inches (144 square inches) region. Otherexamples can use greater or smaller areas for collection including 10inches by 10 inches, 8 inches by 8 inches, 6 inches by 6 inches and 4inches by 4 inches, non-square rectangular regions (e.g., a 9 inches by16 inches rectangle), and non-rectangular regions (e.g. circles).Different-sized templates may be specified for usage with different testsurfaces. The particular template used can be indicated to a readerdevice, for example via a manual user input or via a barcode or otheridentifying pattern on the template scanned by the reader device. Forexample, a template providing a swab area of a 12 inches by 12 inchesregion can be indicated for use in sampling a countertop, while asmaller template demarcating a smaller swab area can be indicated forswabbing an IV pole. The reader device can adjust its test resultcalculations to account for the actual area tested, as indicated by theparticular template used for the sampling procedure.

At block 350, the user can swab the entire test area with thepre-moistened swab. The user can swab the test area using slow and firmstrokes. As shown, the user can methodically pass the swab in straightlines along the height of the test area all the way across the width ofthe test area.

At block 355, the user can insert the swab into the collectioncontainer. In some examples, the collection container includes at-shaped well. Though not illustrated, the swab may have a t-shapedcross-section that substantially matches that of the container well. Theuser seals the container with a top that includes a dripper cap, andfully inverts (e.g., turn upside down and then return to right-side-up)the sealed container five times. During these inversions, the liquid inthe well of the container washes primarily over the swab material due tothe cross-sectional shape and other features of the well, and the handleslides within the well due to the well having a greater height than thehandle. As described herein, the inversion combined with the geometriesof the container and handle and the flow of the buffer solution canextract collected contaminants from the swab material. In onenon-limiting example, the user does not invert or agitate the containerbefore moving to the next step.

At block 360, the user can leave the swab and handle inside thecontainer, remove the dripper cap, and squeeze (or allow gravity todraw) one or more drops (for example but not limited to four drops) intothe sample well on one or more assay cartridges. For example, in someembodiments the user may drop sample onto multiple assays each designedto test for a different drug. In some examples anywhere between threeand ten drops can produce suitable results on the assay. In alternateembodiments the user may mechanically couple a fluid transfer portion ofthe collection device to a fluid transfer portion of the assay device torelease a controlled volume of sample through a closed fluid pathway,for example as shown in FIG. 5C.

At block 365, the user can use a timer to allow the sample to developfor a period of time. For example, the sample can develop for about oneminute, about two minutes, about three minutes, about four minutes,about five minutes, about six minutes, or some other amount of time.Other development times are possible. In some embodiments the timer canbe built in to the programming of the reader device that reads theassay. The development time can vary depending on the particular testthat is being performed and the particular operating parameters of theassay device.

At block 370, the user can insert the assay cartridge into an assayreader device. The assay cartridge can be inserted into the ready deviceprior to or after the sample is developed, depending upon theoperational mode of the device. In some embodiments, the user maysequentially insert multiple cartridges for testing different aspects ofthe sample or for ensuring repeatability of test results.

At block 375, the assay reader device reads portions of the insertedcartridge (including, for example, detecting optical signals fromexposed areas of a capture zone of a test strip housed in thecartridge), analyzes the signals to determine optical changes to testzone location(s) and optionally control zone location(s), determines aresult based on the optical changes, and displays the result to theuser. The device can optionally store the result or transmit the resultover a network to a centralized data repository. As illustrated, thedevice displays a negative result for the presence of Doxorubicin in thesample. In other embodiments the device can display a specific detectedconcentration level in the sample and/or determined for the test area,and optionally can display confidence values in the determined result.

After testing the user can re-seal the container with the dripper capand dispose of the collection device and assay (for example incompliance with hazardous waste regulations). Optionally, the user canreconnect the reader device to its power supply, execute any neededdecontamination procedures, re-test a decontaminated surface, andperform required reporting of the result.

FIG. 3B illustrates another testing method 300B that depicts details ofsteps 350, 355, and 360 of the process 300A using an alternateembodiment of the collection device.

At step 305 the user can remove the handle and swab from the container.As described above, the swab can be pre-wetted for wetting the testsurface with a buffer fluid that helps lift contaminants from the testsurface into the swab and/or the user can separately apply fluid to thetest surface.

At step 310, optionally in some embodiments the swab head can rotate toassist in maintaining contact between the swab and the test surface.

At step 315, the user can swab a designated test area of the testsurface. It can be preferable in some implementations to swab theentirety of the test area and only within the test area so as togenerate an accurate measurement of the concentration of thecontaminant, particularly for contaminants where small quantities perarea are harmful to users. Swabbing the entirety of the test area andonly within the test area can also generate an accurate measurement ofthe concentration of the contaminant in situations where a very smallamount of contaminant is present. Even if the amount of contaminantdetected is very small and not immediately harmful to persons in theimmediate area, detection of contaminant in any amount can alert theuser to a leak or unintended release of hazardous material. As such,some embodiments can include placing a guide or template over the testarea to assist the user with swabbing only the test area.

At step 320, the user can replace the swab and handle into thecollection container. Optionally, the user and/or structure of thecontainer can agitate the swab to release collected contaminants intothe fluid within container. For example, step 330 shows the usersqueezing the sides of the container against the swab head.

At step 325, the user can transfer fluid to a cartridge containing atest strip, or to another test device. For example, the user can dripfluid from the container onto a sample receiving zone.

Though not illustrated, further steps can include inserting thecartridge into a reader device, operating the reader device to performanalyze the test strip, and viewing results of the test.

Overview of Example Closed System Contaminant Collection Devices

Some embodiments of the contaminant collection device can be “closed,”referring to the transfer of fluid from the collection device to thedetection device via a liquid-tight transfer mechanism. For example, thecollection device and detection device (such as a test strip orcartridge holding the test strip) can be structured to couple togetherto provide a fluid tight seal between the liquid-containing portion ofthe collection device and the test strip so that harmful fluids, drugs,or vapors are completely contained and not vented into the atmosphereand possibly creating additional harm to the user. Fluid-tight can referto being liquid impermeable, gas or vapor impermeable, or both,depending upon the properties of the contaminant that the collection kitis designed to detect. Beneficially, this can provide protection to auser of the kit from the potential contaminants in the fluid of thecollection device.

FIG. 4 illustrates an example of a closed system contaminant collectiondevice 400. The collection device 400 can include a handle 405 that canbe releasably coupled with container 420 to provide a fluid-tightenclosure. FIG. 4 shows the handle both coupled with container 420 andseparate from container 420. Mechanisms to couple the handle 405 withthe container 400 can include those described above with reference toFIGS. 1A-, or other suitable mechanisms.

The handle 405 can include cap 415 and grasping tab 410 of cap 415, anelongate handle 425 extending from cap 415 to swab 430, swab 430, and apivot 440. The swab 430 can be constructed from a material havingdesired pickup efficiency and shedding efficiency for detecting traceamounts of contaminants, examples of which are discussed in more detailbelow. Handle 425 can have sufficient length so that the user can swab asurface without physically contacting the surface or the swab 430. Theswab 430 (or a base to which swab 430 is coupled) can be pivotablycoupled to the handle 425 via pivot 440. The handle 425 can be coupledto or an integral part of the cap 415 in some embodiments. A user canhold the handle 405 by the tab 410 during wiping of a test surface.

A liquid, for example a buffer solution, can be provided within thecontainer 420 so that the user removes a pre-wetted swab to wipe thesurface (and optionally pours additional fluid onto the surface from thecontainer 420) in one implementation. In another implementation, theuser can spray the surface with a liquid and collects this liquid withthe swab.

After swabbing the surface, the user places the swab 430 into thecontainer 420 and the cap 415 forms a liquid-tight seal when engagedwith the container 420. The cap 415 can additionally lock to thecontainer.

The container 420 advantageously prevents liquid from spilling andcontaminating surfaces or users, but provides for controlled release offluid to a detection device. The detection device can be an immunoassay,for example a lateral flow assay, with an interface that alerts the userto the presence and/or degrees of contamination. Controlled release ofthe fluid can be provided through a release mechanism, such as valve435, when the container 430 is coupled to a detection device. Thus,valve 435 can be incorporated into a coupling mechanism for coupling thecollection device 400 to a portion of a detection device to create aclosed fluid transfer system.

FIGS. 5A-5D illustrate another example of a closed system contaminantcollection device 500 and an example of a closed system test strip 525.FIG. 5A illustrates a cut-away view of the collection device 500. FIG.5B illustrates the collection device 500 and test strip 525 in aseparated configuration. FIG. 5C illustrates the collection device 500and test strip 525 in a coupled configuration. FIG. 5D illustrates anexample set of fluid transfer couplings for providing a closed fluidpath between the container 505 and test strip 525.

The collection device 500 includes a fluid-tight container 505containing a volume of fluid 510 and swab 515. Collection device 500further includes fluid transfer coupling 520 for providing a fluid-tightmechanical coupling to test strip 525 such that fluid can be transferredbetween the collection device 500 and the test strip 525 withoutescaping from the coupled closed system. A valve 560 of fluid transfercoupling 520 can be biased closed when the collection device 500 andtest strip 525 are separated, and FIG. 5A shows the valve 560 in theclosed position. The valve 560 can include a tapered or contoured lowersurface 565. In some embodiments, the valve 560 can be a split septumvalve, and in some embodiments valve 560 may be a mechanical valve.

The test strip 525 can be housed within a cartridge that includescoupling 530 for mechanically and fluidically coupling to the fluidtransfer coupling 520 of the collection device 500. As illustrated, someimplementations of the coupling 530 can include threads 540 along aninterior of sleeve 545 for mechanically mating the coupling 530 with thethreads 550 of the fluid transfer coupling 520. The coupling 530 canalso include a nozzle 555 having an internal lumen for providing afluidic pathway between the fluid transfer coupling 520 and the coupling530. Nozzle 555 may be a male leur tip in some embodiments. Thecontoured or tapered lower surface 565 of fluid transfer coupling 520may ease connection with the nozzle 555 of the cartridge coupling 530 byguiding the nozzle 555 into the center of the fluid transfer coupling520. In embodiments of the fluid transfer coupling 520 that implement amechanical valve 560, a portion of the valve may open upon contact withthe nozzle 555, either by displacement along the longitudinal axis ofthe fluid transfer coupling 520 or by radial displacement towards thecircumferential edges of the fluid transfer coupling 520. In the openconfiguration, fluid flows through the valve 560 and into the nozzle555.

As the collection device 500 is screwed into the coupling 530, thenozzle 555 can contact the lower surface 565 of the valve 560, therebyopening the valve 560 to release fluid into the nozzle 555. The fluidtransfer coupling 520 can be a needleless connector, for example theMaxPlus™ needleless connector, MaxZero™ needleless connector, BD Q-Syte™luer activated split septum, or SmartSite™ needle-free connectorsavailable from Becton, Dickinson and Company (BD). Some embodiments ofnozzle 555, container 510, and/or fluid transfer coupling 520 can bestructured to allow only a controlled volume of fluid to pass, such as avolume suitable for flowing along the length of the test strip from asample receiving zone to an analyte binding region 535 of the teststrip. In some examples, the desired volume can include three to fourdrops of fluid. Nozzle 555 can be positioned to transfer fluid to thesample receiving zone of the test strip within the cartridge.

As shown in FIG. 5C, when coupled the sleeve 545 of the coupling 530surrounds the fluid transfer coupling 520. Some embodiments of sleeve545 can optionally provide a fluid-tight seal with a lower portion ofthe container 510. In the configuration shown in FIG. 5C, a sealed fluidpathway is established between the container 510 and the samplereceiving zone of the assay test strip via the mated container fluidtransfer coupling 520 and cartridge coupling 530.

FIG. 5D illustrates cross-sections of one example of suitableclosed-path fluid transfer couplings in uncoupled 570 and coupled 580states. The cartridge coupling 530 is illustrated at a high levelwithout the sleeve 545 or threads 540. As illustrated, in the uncoupledstate 570 the valve 560 is closed and the nozzle 555 (e.g., a male luertip) approaches the contoured or tapered lower surface 565. In theuncoupled state 570 the valve 560 extends across the entirecross-section of the fluid transfer coupling 520, preventing egress ofany fluid from the container 505. Pushing the nozzle 555 into the valve560 (for example by threading the fluid transfer coupling 520 andcoupling 530 into the configuration of FIG. 5C) forces the valve 560 toopen around the nozzle 555, thereby establishing an enclosed fluid path590 from the container 505 through the lumen of the nozzle 555. Theillustrated valve 560 is made from a flexible material that enables itto deform around the nozzle 555. Upon removal of the nozzle 555, thevalve 560 automatically returns to the closed position shown in theuncoupled state 570, closing the fluid pathway and preventing spillageof potentially contaminated liquid from the container 505. The couplingsshown in FIG. 5D can be incorporated into any of the collection devicesshown herein, for example into the nozzle 110 of the container 130.

In some embodiments, a user can shake or otherwise agitate thecollection devices shown in FIGS. 4 and 5A-5C prior to transferring thefluid to a detection device in order to release collected contaminantsfrom the swab into the buffer fluid in the container. For example, thecontainer can be inverted a number of times to allow the buffer fluid toflow back and forth across the material of the swab. The buffer fluidcan have properties that assist in releasing collected contaminants fromthe swab material in some implementations, as discussed in more detailbelow. As such, the flow of the buffer fluid can extract thecontamination from the material of the swab and mix it into ahomogeneous solution for testing.

FIG. 6 illustrates example steps of a testing method 600 using a closedsystem contaminant collection device and closed system detection device,such as those described above with respect to FIGS. 4 and 5A-5C.

At step 605, a swab can be inserted into the vial. In some embodimentsthe swab can be integrated into a vial. The vial can be for example, thecontainer 420 illustrated in FIG. 4 , the fluid-tight container 505illustrated in FIG. 5 , or another suitable structure.

At step 610, a cap can be closed to seal the vial. The cap can include aneedleless connector or other closed fluid transfer mechanism asdescribed above.

At step 615, the vial can be inverted above a test strip. Because thevial is fluid-tight, no fluid escapes from the vial during inversion.

At step 620, the vial is coupled, mechanically and fluidically, to theclosed system detection device, in this non-limiting example a teststrip cartridge. A volume of fluid can be expressed from the vial onto asample receiving zone of the test strip in the cartridge.

At step 625, the vial is removed from the test strip cartridge and theintegrated needleless connector re-closes and re-seals to prevent fluidfrom escaping from the closed system contaminant collection device.

Optionally, as shown at step 630, the vial can be disconnected from thetest strip to allow the vial to be coupled to additional test stripsusing the original collected sample. Advantageously, in some embodimentsa test kit can include multiple test strips for testing for differentcontaminants and/or different concentrations of the same contaminant.

Overview of Example Assay Reader Devices and Operations

FIGS. 7A and 7B illustrate an example testing device 700 that can beincluded in or used with hazardous contamination detection kitsdescribed herein. FIG. 7A illustrates the testing device 700 with anassay cartridge 720 inserted into the cartridge receiving aperture 705,and FIG. 7B illustrates the testing device 700 without an insertedcartridge. Examples of the assay cartridge 720 include but are notlimited to the test strip 145 illustrated in FIG. 1A, the test stripillustrated in FIGS. 3A and 3B, the test strip 525 illustrated in FIGS.5B and 5C, and the test strips 630 illustrated in FIG. 6 .

The testing device 700 can be an assay reader device having an aperture705 for receiving an assay test strip and cartridge 720 and positioningthe test strip so that analyte binding regions are positioned in theoptical path of imaging components located inside of the device 700. Thedevice can also use these or additional imaging components to image abar code on the cartridge, for example to identify which imagingtechniques and analysis to perform.

Some embodiments of the device 700 can be configured to perform aninitial scan, for example using a bar code scanner to image one or morebar codes. A bar code can identify the type of test to be performed, theperson conducting the test, the location of the test, and/or thelocation in the facility of the test surface (for example pharmacy,nursing area, cabinet #, bed #, chair #, pump #, etc.). After readingthe bar code identifier the cartridge is then inserted into the readeras shown in FIG. 7A.

The device 700 can have a button 710 that readies the device for use andprovides an input mechanism for a user to operate the device. In someembodiments device operation mode can be set via a number or pattern ofclicks of the single button 710 of the device 700. For example, in someimplementations a single press of the button 710 can power on the device700 and set the device 700 to a default operation mode, and the device700 can implement the default operation mode upon insertion of acartridge. A double-click of the button 710 can initiate an alternateoperation mode that is different than the default operation mode. Othernumbers or patterns of pressing the single button 710 by a user canprovide instructions to the processor of the device regarding a desiredoperation mode. Embodiments of a device 700 are described herein withreference to a single button, but other features allowing a user toselect and switch between device operation modes are possible (such asbut not limited to a single switch, knob, lever, or handle).

One example of a device operation mode is end-point read mode. In theend-point read mode, the user prepares and incubates the assay outsideof the device 700 and tracks the development time of the assay. Forexample, an assay for determining Methotrexate or Doxorubicinconcentration can have a development time of 5 minutes, so the userwould apply the fluid to the assay from a collection device as describedherein and wait for 5 minutes. At the end of the 5 minutes the userwould insert the assay 720 into the device 700 to obtain a test result.Accordingly, when operating in end-point read mode the device 700 canprovide instructions, for example audibly or on a visual display, thatinstruct a user to wait for a predetermined time after applying a sampleto an assay before inserting the assay in the device 700. In otherembodiments, when operating in end-point read mode the device 700 maynot display any instructions but may simply read an assay upon insertioninto the device 700. Upon insertion of the assay into the base device700, an optical reader of the device can collect data (for example,image data) representing the assay for analysis in determining a resultof the assay. In some embodiments end-point read mode can be the defaultoperation mode of the device 700.

Another example of a device operation mode is walkaway mode. Whenoperating in walkaway mode, the device 700 can provide instructions forthe user to insert the assay immediately after or during application ofthe sample. In the walkaway mode according to one embodiment, the usercan apply the specimen to the assay and immediately insert the assayinto the device 700. The assay will develop inside the device 700 andthe device 700 can keep track of the time elapsed since insertion of theassay 720. At the end of the predetermined development time, the device700 can collect data (for example, image data) representing the assay.In implementations where the device 700 is an imaging reader, the device700 can analyze the image data to determine a test result, and reportthe test result to the user. The assay development time can be unique toeach test. In some embodiments walkaway mode can be set bydouble-clicking the single button 710 of the device 700. Further inputcan indicate the assay development time to the reader device. Forexample, a barcode scanned by a barcode reader, or a barcode provided onthe assay or on a cartridge used to hold the assay, can indicate to thedevice 700 a type of assay that is inserted and a development time forthat assay. Based upon the type of assay, the device 700 can wait forthe predetermined amount of time after sample application and insertionbefore collecting image data representing the assay.

There are many advantages associated with the ability of a user toselect and switch between device operation modes in implementations ofbase assay analyzers described herein. The endpoint read mode can beconvenient in large laboratories or medical practice facilities wherepersonnel typically batch process a number of tests. The walkaway modecan be useful when a single test is being performed, or when the enduser does not want to have to track the assay development time (or isnot knowledgeable or not trained on how to track the assay developmenttime accurately). The walkaway mode can advantageously reduce oreliminate the occurrence of incorrect test results due to an assay beinginserted and read (for example, imaged) too quickly (too soon before thedevelopment time of the assay has elapsed) or too slowly (too long afterthe development time of the assay has elapsed). Further, in walkawaymode the assay reader can operate to capture multiple images of theassay at predetermined time intervals, for example when a kinetic graphof the assay readings is desired.

One embodiment of the disclosed device 700 includes only a single button710 on its exterior housing, such as a single power button that powersthe device 700 off and on. Embodiments of the disclosed device 700 alsoimplement two different device operation modes (although more than twodevice operation modes are possible). In order to enable the end user toselect and switch between the two device operation modes, the device 700can include instructions to implement a double-click function on thepower button. After receiving input of a single press of the button topower on the device, insertion of an assay cartridge can automaticallytrigger end-point read mode. When the processor of the device receivesinput from a user double-clicking the power button, this can initiatethe stored instructions to implement the walkaway mode. Thisdouble-click functionality offers a simple and intuitive way for the enduser to switch between different operation modes of the base assayanalyzer. The double-click functionality also enables the user toconfigure the device in real time to operate in the walkaway modewithout requiring any additional configuration steps or additionalprogramming of the device 700 by the user. It will be appreciated thatthe device 700 can be provided with instructions to recognize otherclick modes instead of or in addition to the double-click to triggersecondary (non-default) device operation modes, for example to recognizea user pressing the button any predetermined number of times, pressingthe button in a predetermined pattern, and/or pressing and holding thebutton for a predetermined length of time.

The device 700 can also include a display 715 for displayinginstructions and/or test results to the user. After insertion of thetest strip, the device 700 can read a bar code on the assay test stripto identify the name and/or concentration range of the drug. The device700 can image the inserted test strip, and analyze the signalsrepresenting the imaged test strip to calculate results, display theresults to the user, and optionally transmit and/or locally store theresults. The results can be calculated and displayed as contaminationwith an indication of positive or negative (for example, +/−; yes/no;etc.), and/or the actual contamination per area (for example, DrugConcentration=0.1 ng/cm2) and/or per volume (for example, DrugConcentration=3 ng/ml)

Some embodiments of the device 700 may simply display the result(s) tothe user. Some embodiments of the device 700 may also store theresult(s) in an internal memory that can be recalled, for example, byUSB connection, network connection (wired or wireless), cell phoneconnection, near field communication, Bluetooth connection, and thelike. The result(s) can also automatically be logged into the facilityrecords and tracking system. The device 700 can also be programmed toautomatically alert any additional personnel as required, withoutfurther input or instruction by the user. For example, if the device 700reads contamination levels that are above the threshold of human uptakeand considered hazardous to for human contact, a head pharmacist, nurse,manager, or safety officer can be automatically notified with theresults and concentration of contamination to facilitate a rapidresponse. The notification can include location information, such as butnot limited to a geographic position (latitude/longitude) or descriptionof location (Hospital A, Patient Room B, etc.). That response mayinclude a detailed decontamination routine by trained personnel or usinga decontamination kit provided together or separately from the hazardouscontamination detection kit.

In some embodiments, device 700 can be a special-purpose assay readerdevice configured with computer-executable instructions for identifyingtrace concentrations of contaminants in the samples applied to teststrips. Further components of the device 700 are discussed below withrespect to the diagram of FIG. 8 .

FIG. 7C illustrates a cut-away view showing interior features of anexample of the assay cartridge 720. An assay test strip 723 includingsample receiving zone 724 at a proximal end and analyte binding zone 722at a distal end. The analyte binding zone 722 can be secured within afirst region 721 of the cartridge housing 725. Capillary action cancause applied liquid to flow from the sample receiving zone 724 to theanalyte binding zone 722 along a lateral flow direction 755. The firstregion 721 includes an exit aperture 745 through which any excess fluidoverflowing backwards relative to the lateral flow direction 755 fromthe sample receiving zone 724 is directed. An overflow pad 726 can besecured in a second region 750 (e.g., within a grip portion of thecartridge 720) that is positioned upstream of the first region 721,where “upstream” refers to the second region 750 being positioned closerto the proximal end of the test strip 723 than the first region 721along the lateral flow direction 755. For example, the overflow pad 726can be secured via an aperture 727 and corresponding protrusion 729 onthe cartridge housing 725 or by other suitable fixing features (e.g.clips, adhesives, and/or clamping together of two halves of thecartridge housing 725).

The overflow pad 726 can be made from an absorbent material, and canoperate to absorb any excess fluid that flows out of the assay teststrip 723, thereby preventing such fluid from escaping the housing 725and protecting the user from contacting potentially hazardous fluid. Forexample, if the user drips too much fluid onto the sample receiving zone724, some fluid can run out of the exit aperture 745 and out of theassay strip 723 into the cartridge interior. This fluid can then leakout of the cartridge, spreading any contamination present in the fluid.Embodiments of assay cartridge 720 that include overflow pad 726 cancollect such fluid and contain it within the cartridge 720. If theoverflow pad 726 is placed too close to the assay strip 723 (e.g., incontact with the assay test strip 723) then the overflow pad 726 mayreverse the intended lateral flow direction by drawing out fluid thatwould flow along the assay test strip 723 from the sample receiving zone724 to the analyte binding zone 722 during normal operation. Embodimentsof assay cartridge 720 allow at least some fluid needs to flow away fromthe overflow pad 726 to the analyte binding zone 722 for development oftest results. Accordingly, in some embodiments, the overflow pad 726 canbe spaced apart from the proximal end of the assay test strip 723 by agap 730.

The overflow pad 726 can also be shaped to have a contoured end 740 thatfaces the assay test strip 723, for example shaped as two prongs 740A,740B and a curved edge 740C forming a negative space between the twoprongs 740A, 740B as in the illustrated example. The curved edge 740Cwraps around the exit aperture 745 to block fluid paths of excess fluidtraveling out of the exit aperture 745. Thus, the design of thecontoured end 740 encapsulates the space around the exit aperture 745,thereby absorbing any excess fluid that travels out of the exit aperture745 take so that it cannot escape from the cartridge 720. At the sametime, the curved edge 740C keeps the overflow pad 726 far enough awayfrom the proximal end of the assay test strip 723 to ensure that theoverflow pad 726 does not wick fluid out of the assay test strip 723.

FIG. 8 illustrates a schematic block diagram of one possible embodimentof components of an example assay reader device 800. The components caninclude a processor 810 linked to and in electronic communication with amemory 815, working memory 855, cartridge reader 835, connectivitymodule interface 845, and display 850.

Connectivity module 845 can include electronic components for wiredand/or wireless communications with other devices. For example,connectivity module 845 can include a wireless connection such as acellular modem, satellite connection, or Wi-Fi, or via a wiredconnection. Thus, with connectivity module 845 the assay reader devicecan be capable of sending or uploading data to a remote repository via anetwork and/or receiving data from the remote repository. As such, thetest data of such assay reader devices can be stored and analyzed, aloneor in the aggregate, by remote devices or personnel. A module having acellular or satellite modem provides a built-in mechanism for accessingpublicly available networks, such as telephone or cellular networks, toenable direct communication by the assay reader device with networkelements or other testing devices to enable electronic test resulttransmission, storage, analysis and/or dissemination without requiringseparate intervention or action by the user of the device. In someembodiments connectivity module 845 can provide connection to a clouddatabase, for example a server-based data store. The cloud basedconnectivity module can enable ubiquitous connectivity of assay readerdevices without the need for a localized network infrastructure.

The cartridge reader 835 can include one or more photodetectors 840 forreading an assay held in an inserted cartridge and optionally anyinformation on the inserted cartridge, for example a barcode printed onthe cartridge, and one or more light emitting devices 842 forilluminating the inserted cartridge at one or more wavelengths of light.The cartridge reader 835 can send image data from the one or morephotodetectors to the processor 810 for analysis of the image datarepresenting the imaged assay to determine a test result of the assay.The cartridge reader 835 can further send image data from the one ormore photodetectors representing the imaged cartridge for use indetermining which one of a number of automated operating processes toimplement for imaging the assay and/or analyzing the image data of theassay. The photodetector(s) 840 can be any device suitable forgenerating electric signals representing incident light, for example aPIN diode or array of PIN diodes, a charge-coupled device (CCD), or acomplementary metal oxide semiconductor (CMOS) sensor, to name a fewexamples. The cartridge reader 835 can also include a component fordetecting cartridge insertion, for example a mechanical button,electromagnetic sensor, or other cartridge sensing device. An indicationfrom this component can instruct the processor 810 to begin an automatedassay reading process without any further input or instructions from theuser of the device 800.

Processor 810 can be configured to perform various processing operationson image data received from the cartridge reader 835 and/or connectivitymodule interface 845 in order to determine and store test result data,as will be described in more detail below. Processor 810 may be ageneral purpose processing unit implementing assay analysis functions ora processor specially designed for assay imaging and analysisapplications. The processor 810 can be a microcontroller, amicroprocessor, or ASIC, to name a few examples, and may comprise aplurality of processors in some embodiments.

As shown, the processor 810 is connected to a memory 815 and a workingmemory 855. In the illustrated embodiment, the memory 815 stores testresult determination component 825, data communication component 830,and test data repository 805. These modules include instructions thatconfigure the processor 810 of device 800 to perform various moduleinterfacing, image processing, and device management tasks. Workingmemory 855 may be used by processor 810 to store a working set ofprocessor instructions contained in the modules of memory 815.Alternatively, working memory 855 may also be used by processor 810 tostore dynamic data created during the operation of device 800.

As mentioned above, the processor 810 may be configured by severalmodules stored in the memory 815. The test result determinationcomponent 825 can include instructions that call subroutines toconfigure the processor 810 to analyze assay image data received fromthe photodetector(s) 840 to determine a result of the assay. Forexample, the processor can compare image data to a number of templatesor pre-identified patterns to determine the test result. In someimplementations, test result determination component 825 can configurethe processor 810 to implement adaptive read processes on image datafrom the photodetector(s) 840 to improve specificity of test results andto reduce false-positive results by compensating for background andnon-specific binding.

The data communication component 830 can determine whether a networkconnection is available and can manage transmission of test result datato determined personnel and/or remote databases. If the device 800 isnot presently part of a network, the data communication component 830can cause local storage of test results and associated information inthe test data repository 805. In some case, the device 800 can beinstructed to or automatically transmit the stored test results uponconnection to a network. If a local wired or wireless connection isestablished between the device 800 and another computing device, forexample a hospital, clinician, or patient computer, the datacommunication component 830 can prompt a user of the device 800 toprovide a password in order to access the data in the repository 805.

The processor 810 can be configured to control the display 850 todisplay captured image data, imaged barcodes, test results, and userinstructions, for example. The display 850 may include a panel display,for example, a LCD screen, LED screen, or other display technologies,and may implement touch sensitive technologies.

Processor 810 may write data to data repository 805, for example datarepresenting captured images of assays, instructions or informationassociated with imaged assays, and determined test results. While datarepository 805 is represented graphically as a traditional disk device,those with skill in the art would understand that the data repository805 may be configured as any storage media device. For example, datarepository 805 may include a disk drive, such as a hard disk drive,optical disk drive or magneto-optical disk drive, or a solid statememory such as a FLASH memory, RAM, ROM, and/or EEPROM. The datarepository 805 can also include multiple memory units, and any one ofthe memory units may be configured to be within the assay reader device800, or may be external to the device 800. For example, the datarepository 805 may include a ROM memory containing system programinstructions stored within the assay reader device 800. The datarepository 805 may also include memory cards or high speed memoriesconfigured to store captured images which may be removable from thedevice 800.

Although FIG. 8 depicts a device having separate components to include aprocessor, cartridge reader, connectivity module, and memory, oneskilled in the art would recognize that these separate components may becombined in a variety of ways to achieve particular design objectives.For example, in an alternative embodiment, the memory components may becombined with processor components to save cost and improve performance.

Additionally, although FIG. 8 illustrates a number of memory components,including memory 815 comprising several modules and a separate memory855 comprising a working memory, one of skill in the art would recognizeseveral embodiments utilizing different memory architectures. Forexample, a design may utilize ROM or static RAM memory, internal memoryof the device, and/or an external memory (e.g., a USB drive) for thestorage of processor instructions implementing the modules contained inmemory 815. The processor instructions may be loaded into RAM tofacilitate execution by the processor 810. For example, working memory855 may comprise RAM memory, with instructions loaded into workingmemory 855 before execution by the processor 810.

Overview of Further Examples of Contaminant Collection Devices

FIGS. 9A and 9B illustrate examples of a contaminant collection device900A, 900B that can be used in hazardous contamination detection kitsdescribed herein. FIG. 9A illustrates a cross-sectional view of a firstembodiment of the collection device 900A with a handle 905 removed froma container 925. FIG. 9B illustrates another embodiment of thecollection device 900B with the handle 905 removed from the container925 and a cap 935 in the container 925.

The collection device 900A, 900B includes a swab 915 attached to ahandle 905 that allows the user to wipe the surface to be tested byholding only the handle 905 and not contacting the surface. After wipingthe surface, the handle is inserted into a container 925 with additionalbuffer solution (not illustrated). When the handle 905 is inserted intothe container 925, the sides of the handle seal with the interior of thecontainer, for example by O-ring 910. As the handle approaches thebottom of the container, either by simply pressing or with theassistance of a threaded engagement between the handle 905 and thecontainer 925, the buffer solution is pressurized and forced through theswab fabric, through small holes 920 in the handle, and into the handleinterior. Partial removal of the handle can create a vacuum, sucking thebuffer solution back through the swab fabric again. Repeating thisprocess multiple times helps to flush the collected contaminations fromthe fabric creating a homogeneous solution. The structure of thecollection device 900A, 900B positively forces the buffer fluid throughthe fabric as a means of extracting the contamination from the fabric.

A needleless connection system, such as that discussed above withrespect to FIGS. 5A-5C, can be incorporated into the handle 905 to allowfor the closed transfer of buffer solution from the interior of thehandle to a test device. The embodiment 900A of FIG. 9A does not show aneedleless connection system. The embodiment 900B of FIG. 9B includesthreads 930 to assist in the creation of the pressure and vacuum as wellas an attachment point for the needleless connector. FIG. 9B also showsa cap 935 for the container 925 to contain the buffer solution untiluse.

FIG. 10A illustrates another example of a contaminant collection device1000A that can be used in hazardous contamination detection kitsdescribed herein. In this embodiment, a swab material 1010 is attachedto a detachable base 1020 of a handle 1005, which is then attached tothe handle 1005 using a releasable attachment mechanism similar to arazor handle. After the user swabs a surface (using a motion similar tousing a razor to shave), the swab base 1020 can be disconnected from thehandle 1005 and dropped into a container 1015 containing a buffersolution. The container can be capped and then inverted a number oftimes to flow the buffer solution back and forth across the swab 1010 toextract any contaminants. The container 1015 can include an interiorportion shaped to correspond to the shape and size of the swab 1010,similar to the FIGS. 1A-1L configuration. In one example where device1000A is a closed system contaminant collection device, the container1015 may contain a needleless connection system as described above,either in the bottom of container 1015 or as part of a cap (not shown),in order to transfer the buffer mixture to a test device. In anotherexample where device 1000A is an open system contaminant collectiondevice, the cap may also contain an orifice that allows for single dropsof the buffer mixture to be dripped out of the container onto the teststrip.

FIG. 10B illustrates another example of a contaminant collection device1000B that can be used in hazardous contamination detection kitsdescribed herein. Similar to collection device 1000A, collection device1000B includes a swab material 1010 attached to a handle 1005. A tray1035 having a number of swab cartridges 1025 can be provided with thehandle 1005. Each cartridge 1025 can secure a swab material to a firstsurface, and a second surface opposing the first surface can include anattachment device 1030 for releasably attaching to the handle 1005. Asillustrated, attachment device 1030 can be a pair of prongs, or in otherembodiments can be any suitable structure for press-fitting, snapping,hook-and-eye latching, or otherwise attaching to the handle. Handle 1005can be provided with a release mechanism 1040, for example a button orlever, so that the user can release the cartridge 1025 and attached swab1010 without contacting the swab 1010.

The contaminant collection device 1000B of FIG. 10B also includes aclosed fluid transfer system 1050 for containing a used swab cartridge1025 and attached swab 1010 between wiping the test surface andperforming a test to analyze the sample. The closed fluid transfersystem 1050 can include a handle 1060 having a grip portion 1055 and acartridge well 1065 spaced away from the grip portion 1055 for securinga used cartridge 1025 away from the fingers of a user. The handle 1060can be inserted into a fluid-tight container 1070 that sealingly engagesthe handle to prevent escape of enclosed fluids. The closed fluidtransfer system 1050 can further include a fluid-tight fluid transfermechanism 1045 in some embodiments, for example a needleless connectoras described above, for transferring the enclosed fluid to a testdevice. Fluid can be expelled from the fluid-tight container 1070 insome embodiments by the user pressing or twisting the grip portion 1055to compress or wring the enclosed cartridge 1025.

FIG. 11 illustrates an example of a pivoting collection device swab 1100that can be used in hazardous contamination detection kits describedherein. A handle 1110 includes a grip portion 1105, an elongate swabhandle 1115 having a pivot 1120 connected to a swab head 1125, and aswab 1130. Such a pivoting head can be used, in some examples, in thecollection device 400 described above.

The benefits of a pivoting head are two-fold. First, the pivoting headenables the user to have access to a large swab head reducing the needfor multiple passes when swabbing the potentially contaminated surfaces.Second, the pivoting head creates a compact swab handle/vial system whenthe handle is inserted into the buffer vial enabling a minimal amount ofbuffer required as well as requiring minimal storage space. The buffervial (not shown, see FIG. 4 for an example) can also be designed to belong and slender and interact with the swab-head such that when theswab-head handle is inserted into the buffer vessel it will serve toagitate the swab material facilitating a more efficient release of thecollected sample into the buffer material. This can be accomplished viaa snug-fit as well as internal geometry (ribbing, bumps, bottle-neck,etc.) to compress/agitate the swab 1130 when the handle is inserted intothe container. A variation on the design is to mold the vial out of asofter compliant plastic allowing the user to squeeze the tube againstthe inserted swab head facilitating a greater release of sample from theswab head.

The pivoting joint 1120 that connects the swab head to the handle can belocated anywhere along the swab head. Another aspect of this embodimentsinvolves moving the pivoting location away from the center toward oneend of the swab head 125. This can cause the swab head to rotate fromthe horizontal wiping/sampling position into a more vertical position tomore easily present the swab head into the more compact vial. This alsohas the advantage that any residual fluid would pool up at the distalend of the swab head when it is rotated and drip into the vial, asopposed to dripping on the table or sampling surface. Reducing lostvolume of captured fluid and drug is also beneficial for more accuratesampling results. In the illustrated embodiment, the preferred positionof the pivoting joint ranges from about 25% to 75% of the distance fromthe center of the swab/wipe head to the end of the swab head. This canprovide enough stability when wiping and an increased tipping momentwhen lifted from the surface and presented at the vial to complete theremainder of the process.

When pressed against the surface to be swabbed, the swab head 1125complies in a rotating motion to lay flat against the surface, therebyproviding contact between a larger surface area of the swab material andthe test surface compared to non-pivoting embodiments that may bepositioned at an angle to the test surface. Upon completion of swabbing,the handle can be inserted into the vial and the swab head can rotatein-line axially with the handle, enabling it to slide into a slenderbuffer vial. The insertion of the handle into the buffer vial cansimultaneously agitate the swab material to express out both diluent andcollected sample substances into the vial.

The embodiment of FIG. 11 can provide several advantages: 1) a largerswab-head surface reducing the number of passes along the surface thatwould be required to collect the sample, 2) a matching vial which cancontinue to be slender and compact reducing the need for a large amountof diluent, and 3) providing a more robust handle configuration so theuser can press against the surface with an adequate amount of pressure(test results indicate that pressure and friction are the leadingsuccess factors to obtaining an adequate amount of substances from thesurface).

An example of using the swab 1100 of FIG. 11 is shown in FIGS. 3A and3B.

Contamination collection devices described herein can be designed toimprove the efficiency terms of the concentration equation above, forexample as illustrated in FIGS. 12 and 13A-13B. If the pick-upefficiency level can be increased, and the variation in pick upefficiency can be lowered, then efficiency can be increased to itshighest possible level (with low variability) and the determinedconcentration will be more accurate. If the pick-up efficiency is toolow the result would be a false negative result to the end user. If theuser thinks that their collection kit picked up all of the drug on thecontaminated surface for testing but in reality it did not, thencontamination would remain on the test surface, and the reader wouldread a value that is lower than it should be. This lower value couldlead to a false reading, and individuals in the contaminated environmentcould be exposed to possibly more hazardous values.

The embodiments of FIGS. 12 and 13A-13B reduce the number of collectionsteps by utilizing and combining two technologies in the pick-upprocess. A swab can be used to dispense liquid buffer solution onto thetest surface, then a squeegee can be used to collect the buffer andwiped solution and concentrate it into a pool for the swab to re-absorb.The combination of these two elements integrated in the same device inclose proximity can simplify the workflow of wetting and wiping thewetted surface. As a result of having a combined squeegee featuredirectly behind or in close proximity to the swab, the squeegee featurewipes the surface and the swab is in such close proximity that itautomatically re-absorbs the fluid.

The friction and pressure generated by the squeegee can leave apotentially contaminated surface more “clean” from contaminants than itwas prior to testing by wiping and concentrating the contaminated drugand providing the solution in close proximity to the swab for pick-up.The use of the squeegee and swab together can allow the user to usefewer steps in the collection and wiping process and provide higherpick-up efficiencies with lower variation.

FIG. 12 illustrates an example of a squeegee collection device 1200 thatcan be used in hazardous contamination detection kits described herein.The squeegee collection device 1200 includes a handle 1205, a swab 1210coupled to one end of the handle, and a squeegee 1225 that trails behindthe swab 1210 when wiped across a surface in order to collect liquid1220 not initially picked up by the swab between the squeegee 1225 andswab 1210. The handle 1205 can be held by a user manually operating thesqueegee collection device 1200 in some embodiments. In otherembodiments, handle 1205 can be modified or omitted in order to couplethe squeegee collection device 1200 to an automated system for wiping atest surface automatically and autonomously. The automated system can beprovided with a motorized drive mechanism and instructions for travelingacross, and collecting sample from, a predetermined area.

FIGS. 13A and 13B illustrate another example of a squeegee collectiondevice 1300 that can be used in hazardous contamination detection kitsdescribed herein. FIG. 13A illustrates a top view of the squeegeecollection device 1300 and FIG. 13B illustrates a perspective view ofthe squeegee collection device 1300. The squeegee collection device 1300includes a handle 1320 and a swab 1315 coupled to one end of the handle.Squeegee collection device 1300 also includes a trailing squeegee 1310that trails behind the swab 1315 when wiped across a surface in order tocollect any liquid not initially picked up by the swab between thesqueegee 1310 and swab 1315. Squeegee collection device 1300 alsoincludes a pair of lead directing squeegees 1305 that direct fluid infront of the device 1300 inward (toward a center axis of the device)toward the swab 1315. This can allow for a decreased size of the swab1315 and trailing squeegee compared to the embodiment of FIG. 12 .

Providing at least a trailing squeegee as shown in FIGS. 12 and 13A-13Bcan improve collection efficiency by collecting fluid that the swabwould not ordinarily absorb as it travels over the fluid, thus exposingthe swab to the fluid for a longer time and allowing the swab to absorbthe excess fluid. Thus, in the embodiments of FIGS. 12 and 13A-13B, theabsorbent swab and squeegees can contact different portions of the testsurface simultaneously when in use.

In order to track the area swabbed for more accurate test resultcalculations, some embodiments of the disclosed collection devices caninclude an odometer to track the distance that the collection device hastraveled. This distance can be displayed to the user and manuallyentered into a detection device or electronically transmitted from thecontaminant collection device to the detection device in variousembodiments. FIGS. 14A-14D illustrate various embodiments of acontaminant collection device with a built-in odometer. FIG. 14Aillustrates a distance-tracking collection device 1400A that has a wheel1410 configured to track the distance that the device 1400A travels asit is rolled across a surface, and also includes a display 1405 forproviding an odometer reading. FIG. 14B illustrates a distance-trackingcollection device 1400B that includes a handle 1425, swab 1420, and aroller ball 1415 integrated into the swab area to provide for trackingof the distance traveled by the swab. Although not illustrated in FIG.14B, a distance-tracking collection device 1400B can include a displayfor displaying an odometer reading to the user. FIG. 14C illustrates atop view of a distance-tracking collection device 1400C that includes ahandle 1430, a swab 1440, and an integrated roller wheel 1435 centrallylocated in a swab 1440. FIG. 14D illustrates a front perspective view ofthe distance-tracking collection device 1400C.

Another embodiment can include a swab provided integrally with an assaytest strip such that a user can directly capture a sample from a surfaceusing the test strip.

Overview of Example Fluid Removal

FIG. 15 illustrates various examples of removal of fluid from swabs incontaminant collection devices 1500A, 1500B, and 1500C. One embodimentof a contaminant collection device 1500A can include ridges 1505 alongan interior of a container sized such that, when a swab 1510 is insertedinto the container, the ridges compress the material of the swab 1510 inorder to expel collected fluid from the swab 1510. Another embodiment ofa contaminant collection device 1500B can include one or more layers ofcircumferentially disposed protrusions 1515 at or near an entrance tothe interior of the container and/or disposed along the interior sidesof the container. The protrusions 1515 can squeeze and scrape the swab1510 as it is inserted into the container in order to expel collectedfluid from the swab 1510. Another embodiment of a contaminant collectiondevice 1500C can include a flexible container 1525 sized to receive aswab 1520 and configured to be wrung, where sides of the swab arerotated in opposing directions, in order to expel fluid from the swab1520. In some cases, a controlled volume of fluid can be expelled fromone end of the flexible container 1525 as the ends are twisted inopposing directions.

FIG. 16 illustrates an example of a dissolvable swab system 1600 thatcan be used in hazardous contamination detection kits described herein.In some embodiments, swab 1610 can be constructed from a material thatdissolves upon contact, or after prolonged contact, with a buffersolution or other liquid. In some embodiments, a first buffer solutioncan be provided to the test surface for lifting contaminants off of thesurface for pick-up by the swab, and the swab may not dissolve incontact with the first buffer solution so that the swab can be used towipe the entire demarcated area. A second buffer solution or otherliquid 1615 can be contained within container 1605 to dissolve the swab1610 into the liquid of the container after the swab 1610 is introducedinto the container. Dissolving the swab into the liquid in the containercan provide the benefits of a more homogenous mixture for testing and ofnot retaining any contaminant in the swab when the container liquid istransferred to a detection device.

FIG. 17 illustrates example steps for a method 1700 of collectingcontaminant from a test surface using an oversaturated collection deviceswab. The method 1700 can be implemented by any of the contaminantcollection devices described herein.

At step 1705, a user can obtain a fully saturated swab attached to ahandle, for example by withdrawing the swab from its own packaging orfrom a pre-filled collection container. Fully saturated as used hereinrefers to the swab containing a sufficient volume of fluid such that,when compressed, the swab material will release the fluid to arelatively large area (larger than the area directly contacted by theswab) of the test surface. Fully saturated swabs can contain all of adesired volume of liquid such that the liquid does not drip out of thematerial. In other embodiments a swab that is oversaturated (such thatliquid is intended to drip out of the material) can be provided.

At step 1710, the user can squeeze the swab, such as by pressing theswab against the test surface while holding the handle, causing fluid tobe expelled from the swab.

At step 1715, after (or as) the fluid is expelled the user can scrub orwipe the surface, passing the swab material over the expelled fluid,until it is completely or almost completely absorbed into the swabagain. In some embodiments, steps 1710 and 1715 can be repeated overdifferent areas of a demarcated test surface area until the entire areahas been swabbed.

At step 1720, after acquiring the sample from the test surface, the usercan place the swab into a vial in order to contain the fluid.

At step 1725, the user can squeezing the swab again by compressing thematerial into the bottom of the vial, thereby expelling the sample. Insome embodiments, the vial can be coupled to a separate collectionchamber so that the expelled fluid is stored for testing and notre-absorbed into the swab. The user can subsequently transfer the fluidfrom the vial or collection chamber to a detection device via any of theopen or closed fluid transfer systems described herein.

Overview of Example Networked Testing Environment

Aspects of the present disclosure relate to a contamination test datamanagement system. There are drug preparation systems, surfacecontamination tests, and healthcare worker safety procedures in thehospital and other healthcare delivery environments. These three areasare connected only to the extent that they have a common goal: to reduceor eliminate healthcare worker exposure to hazardous drugs, and toensure patients are provided correct drug doses. The described hazardouscontamination detection kits, systems and techniques improve uponexisting approaches by linking these three areas, sensing patterns andtrends, and targeting worker feedback and training. By creating andanalyzing associations between data regarding dose preparation,personnel activities, and contamination test results, the disclosedsystems can provide information to healthcare workers and managementtargeted at risk identification, feedback, and training. A beneficialoutcome can include behavioral and/or workflow changes to reduceexposure risk in the test areas.

There are several existing solutions for assisting with pharmacy (orother clinical setting) drug preparation workflow. Each of these systemsis designed to enhance patient safety through automated preparation orverification steps in compounding drugs. These systems are often usedwith hazardous drugs, such as chemotherapy agents, because there islittle room for error with these drugs due to the health risks ofexposure to even trace amounts. One such system performs automated dosecalculation, weight-based (gravimetric) preparation and verification,integrated drug and consumable barcode verification, real-time automateddocumentation of the compounding process, and step-by-step compoundingguidance. Other examples can employ a camera that captures images ofproducts used in dose preparation and optionally an integrated weighingscale design with step-by-step guidance and automatic documentation.

While these systems help automate several aspects of drug preparation,they do not address pre- and post-preparation issues in the pharmacy,such as managing data associated with surface contamination testing (forexample, floors, walls, hoods, etc.). They also do not manage dataassociated with air testing, nor data from testing individuals viafingertip, urine, blood or any other personal exposure monitoring.

Surface wipe tests are available from companies such as ChemoGLO™ whichprovide quantitative analysis of the antineoplastic agents5-fluorouracil, ifosfamide, cyclophosphamide, docetaxel and paclitaxel.An example existing kit contains enough materials to conduct six surfacewipes. The wipes and samples are sent to an outside laboratory, andreports are provided back to the test location within three to fourweeks. Such tests and delayed reports are disconnected processes fromday to day activities in the pharmacy.

Hazardous drugs, particularly chemotherapy drugs, are known tocontaminate surfaces and air in pharmacies and other patient caresettings, which presents a significant health risk to pharmacy and otherhealthcare workers. Further, the United States Pharmacopeia (Cpater 797,28th Rev) recommends sampling of surfaces for contamination withhazardous drugs at least every six months. With improved testingtechnology, better feedback and improved outcomes, the frequency oftesting is expected to become a more routine activity.

FIG. 18 depicts a high level schematic block diagram of an examplenetworked test system environment 1800. Hazardous contaminationdetection kits described herein can be used in the networked test systemenvironment 1800 to improve contamination detectin, risk identification,feedback, and training. The networked environment 1800 includes a userinterface 1805, dose preparation system 1820, surface contamination test1825, and reporting system 1815 in network communication with a centralserver 1810 (and/or one another) via a network. The network can be anysuitable data transfer network or combination of networks includingwired networks and/or wireless networks such as a cellular or otherpublicly accessible network, WiFi, and the like.

The user interface 1805 supports system interaction by the test operatorand can be located in the work area, for example in or near the testingenvironment. This facilitates interaction without the test operatorhaving to remove and reapply personal safety equipment in order to usethe system.

The dose preparation system 1820 can be hardware associated with agravimetric dose preparation system, a scale, robotics, or devices thatare designed to assist in the preparation of safe drug doses for thepatient.

The surface contamination test 1825 can include a local test processingsystem which is in network communication with at least the centralserver 1810. For example, the local test processing system can be theassay reader device 800 of FIG. 8 .

Central server 1810 can implement the algorithms, decisions, rules, andheuristics involved with management of contaminant testing data, and canstore data (individual and aggregate), handle data input and/or output,generate reports, provide the user interface, and the like. Thoughreferred to as a central server, these functions could be carried out ina distributed fashion, virtually, in any location.

The reporting user interface 1815 can provide raw and processed data tothe user or safety manager regarding the relationship between activitiesin the pharmacy and test results.

In some implementations, the above descriptions apply to tests that areperformed immediately in a pharmacy, hospital, or other clinicalsetting. However, the described testing is not limited to architectureswhere instant, immediate, or real-time connectivity is available. Forexample, if a local wipe test processing system is not available, datafrom a remote system can be transmitted to the central server using anynumber of methods. Results from tests may be fed in to an interfacemanually, electronically encoded, or in machine readable format. Datanetworks (e.g., internet, wireless, virtual private, cloud-based) can beused to input data from a remote lab (outside the pharmacy, hospital, orclinic) that performs testing either immediately or at a later time. Themain difference between immediate local contamination detection versusremote testing is a potential time delay. As described above, currentcontaminant detection occurs in a two-step process with the stepsperformed at different locations. First, collection happens at site ofpossible contamination. Collection occurs a time A. Second, detection ofthe contamination occurs in a laboratory facility geographicallyseparate from the contamination. Detection occurs at a time B, which isweeks or even months after collection occurred. The present disclosureprovides a system including collection device and detection device inone kit. Using the disclosed kit, collection and detection occur at thesite of possible contamination, and detection occurs within minutes ofcollection. For example, collected fluid can be provided onto an assayimmediately (for example, within seconds such as but not limited towithin 1, 2, 3, 4, 5, 10, or 15 seconds) after agitation of the fluidwithin a container as described herein. The collected fluid can beprovided to the assay for up to 3 hours (360 minutes) after agitation insome embodiments. In some embodiments, instructions for use include arecommendation to the user not to apply the collected fluid to the assaymore than 3 hours after collection because accuracy may decrease after 3hours. After the fluid is added to the assay it can take around fiveminutes to fully develop in some non-limiting examples. In oneadvantageous implementation, the assay is read by a detection systemaround the time of its complete development. As such, the disclosed kitscan provide test results indicating the presence, absence, and/or degreeof contamination between 2-365 minutes after completion of samplecollection, in some embodiments. Laboratory testing of embodiments oftest kits described herein has demonstrated that reliable results can beobtained within about 5 minutes of completion of sample collection, andin some cases in as little as 2 minutes of completion of samplecollection. This represents a dramatic improvement in the time to obtaina test result indicating the presence, absence, and/or degree ofcontamination of a hazardous drug over prior systems.

Embodiments of the system 1800 described herein directly link activitiesperformed in the test environment to test results. For example, thesystem 1800 can directly link contaminant test results to whenactivities (for example, during antineoplastic drug preparation, dosing,and the like) were performed, who performed these activities (forexample, through authentication), where the activities occurred (whichhood, nearby floor, air test), and other events (such as spills, wastingof materials, or improper waste disposal) which can be manually orautomatically recorded. In some embodiments, the central server 1810 canperform analysis of the related information to identify trends inhazardous contamination levels, and can output recommendations forpreventing or mitigating hazardous contamination levels in certainareas.

FIG. 19 depicts a flow chart of an example process 1900 for test datageneration, analysis, and reporting that can be implemented in someembodiments of the system 1800 of FIG. 18 .

The dose preparation system 1820, whether volumetric, gravimetric,photographic, or bar code scanning, can be capable of keeping a recordof every dose that was prepared in a particular pharmacy hood or otherwork area or clinical care area, when the dose was prepared and/oradministered, and who prepared and/or administered the dose (forexample, the identity of the pharmacy technician). As described above,this information can be correlated with the results of the contaminationtest.

The correlation algorithm can, in some embodiments, match detectedcontamination with specific personnel who might have created orcontributed to the contamination. For example, if three techniciansworked in a hood, and only one worked with compound x, and compound xwas identified in a contamination test, then the technician who workedwith compound x might be targeted for training or follow up testing.

The correlation algorithm can, in some embodiments, providecontamination test guidance by limiting tests to compounds that wereactually used over a period of time, or used since the lastcontamination test. In a scenario where more than one test is requiredto screen for multiple possible contaminants, the cost may increase fora number of reasons. For example, it may take a longer period of time toperform testing due to more samples being needed. The time it takes torun a test may be longer. Sample preparation may be more complex. Eachtest may have an incremental cost, so tailoring tests may lower theoverall cost. Advantageously, the dose preparation system could directthe user, or an automated system, to perform only contamination testsfor drugs that were prepared in a specific location or hood.

The correlation algorithm can, in some embodiments, improve thespecificity of contamination tests by utilizing a priori knowledge ofdrugs that were prepared in the hood. For example, if a contaminationtest shows a positive result, but is not capable of indicating which ofa family of possible contaminants actually has been identified, thedatabase of drugs prepared in the hood could be queried for all of thosepossible drugs, and the test result narrowed to the ones actuallyprepared. In some implementations, further testing can be performed forthose specific drugs.

The correlation algorithm can, in some embodiments, determine systematicissues with devices used in preparing drugs. Drug preparation systemscan have the capability to store information representing the productsand devices used in drug preparation. For example, information onsyringe types (manufacturer, volume etc.), closed system transferdevices, connectors, spikes, filters, needles, vials, and IV bags, toname a few examples, can be stored along with the drug and diluent datain the preparation systems database. Failures can be linked to specificdevices and directly help with risk mitigation.

The correlation algorithm can, in some embodiments, identify drugmanufacturers, dose and containers that systematically fail, resultingin detected contamination. The correlation algorithm can identifyprocedures that commonly cause contamination, such as reconstitutionsteps.

The system 1800 can provide some or all of these analytics, alone or incombination, in various embodiments.

The system 1800 can be designed to implement workflows that areinitiated based on a set of conditions. For example, one condition thatcan trigger a workflow is the detection of contamination. Examples ofworkflows are described below.

A decontamination workflow can include the following procedures. Thesystem 1800 can instruct a user how to contain and decontaminate aspecific area, depending on what area the test was performed in.Instructions can include audio, text, video, and the like. Afterdecontamination, the workflow can continue to instructions on performingrepeat contamination tests to ensure the area was properlydecontaminated. If testing fails again, the decontamination procedurecan be repeated.

The system 1800 can be configured to provide instructions through theuser interface 1805 and/or dose preparation system 1820 (or any othermeans of communication, including printed instructions, other displays,voice output and input, direct messages to designated users, etc.).These instructions can be configured to be specific for certain sourcesof contaminants.

Another example workflow is repeat testing of the area of contamination,prior to decontamination. This may be a useful workflow if thespecificity of a particular test is not high. The objective could be tore-test with the same test, or perform further tests to identify morespecifically, what the source and/or level of contamination is. Afollow-on step could be specific decontamination instructions, alreadydescribed above.

In various workflows, system 1800 can be configured to receive, prompt,and/or wait for input during the workflow to acknowledge completion ofeach step. The system 1800 can be configured to capture decontaminationprocedure evidence, such as photographic, video, audio, proximityinformation for future review, training, documentation, and the like.

System 1800 can be configured to identify risks from preparation issues.For example, the system 1800 can analyze data already captured by a drugpreparation system, or provide means to capture data regarding drugpreparation issues, problems or errors. For example, when material iswasted, the user involved can be questioned about whether there was aspill or any surface contamination that caused the wasting. System 1800can link wasting with positive contamination tests, if wasting iscommonly caused by spills.

System 1800 can be adapted for use in non-pharmacy healthcareenvironments including, but not limited to, hospitals, clinics, hospiceenvironments, and veterinary treatment centers. The system 1800 can beadapted to other areas of patient care, such as the patient floor,nursing, drug delivery (e.g., infusion, injection), patient room,bathroom, etc. Contamination tests can be performed in any of thesesettings, and this data can be fed back to the system 1800. As describedabove, detected contamination can be correlated with personnel,protocols followed, specific drugs, devices, locations, and any otherparameter of interest. Any parameter around the delivery of drugs thatcan be encoded can be correlated with the presence of contamination toprovide feedback to risk managers, clinical and pharmacy personnel.Further, dose preparation and dispensing can occur in many locationsoutside the pharmacy, and similar workflows can be employed in thoseareas, including remote contamination test preparation and execution.

The physical location of specific functions performed by the system 1800are not restricted to the pharmacy or hospital data center. Anystructure or function of the system 1800, including the database,correlation and analysis, data entry, data display, reporting, etc., canbe carried out in any system in any location. A system model may be tohave a central web-based service, for example. Another model may be tohave remote reporting and notification capability through remote deviceslike smart phones, pagers, computers, displays, applications etc.

Supply of devices can be automated through any of the previouslydescribed systems. For example, pharmacies may be provided resupply oftest kits by system 1800, and such resupply can be automated in someembodiments by managing an inventory of kits and initiating a resupplywhen stock falls below a certain level.

Overview of Example Swab Materials and Buffer Solutions

Considerations in the development and selection of swab materials andbuffer solutions will not be described. Optimal swab materials andbuffer solutions will be identified, but it will be understood thathazardous contamination detection kits described herein can use anysuitable swab material and buffer solution. Three criteria for choosinga swab for use with the described contamination collection devicesinclude the following. (1) Minimal background—Background is the amountof contaminant on a swab measured by the analytical technique aftertesting has been performed according to the analytical protocol beforesampling. Blank contribution from the swab must be minimal. (2) Highrecovery rate—Recovery means the percentage of contaminant actuallymeasured by the analytical technique when the swab is spiked with aknown quantity of that species. In one non-limiting example, asixty-percent recovery rate is deemed acceptable; however, higherrecovery rates are desirable. (3) Low particle generation—It isdesirable that the swabbing material leave the swabbed surface free fromparticles which would further contaminate the surface.

Through extensive testing, some of which is summarized below, it hasbeen discovered that cleanroom-laundered, 100 percentcontinuous-filament, double-knit polyester materials can meet all therequirements for swabbing: minimal background, high recovery rates, andlow particle generation. Swabs made with cleanroom-laundered 100 percentpolyester-knit heads feature low particle generation and extremely lownonvolatile residues. Thus, some embodiments of the swabs describedherein can include one or more layers of such material.

In some embodiments, swab material can be interrelated with the buffersolution. For example, polyester swabs can exhibit high collectionefficiencies, but for buffer solution types with no surfactant, foamswabs can perform better than polyester swabs. Tris buffer and ChemoGlosolution are two suitable buffer solutions that can be implemented incontamination collection devices described herein. Other buffersolutions are also suitable, for example HEPES buffer. Polyester swabscan be used with Tris buffer and other solutions with surfactant, whilefoam swabs can be used with ChemoGlo or other drying solutions, such asthose containing alcohol.

Implementing Systems and Terminology

Implementations disclosed herein provide systems, methods and apparatusfor detection of the presence and/or quantity of antineoplastic agentsor other environmental contaminants. One skilled in the art willrecognize that these embodiments may be implemented in hardware or acombination of hardware and software and/or firmware.

The assay reader device may include one or more image sensors, one ormore image signal processors, and a memory including instructions ormodules for carrying out the processes discussed above. The device mayalso have data, a processor loading instructions and/or data frommemory, one or more communication interfaces, one or more input devices,one or more output devices such as a display device and a powersource/interface. The device may additionally include a transmitter anda receiver. The transmitter and receiver may be jointly referred to as atransceiver. The transceiver may be coupled to one or more antennas fortransmitting and/or receiving wireless signals.

The functions described herein may be stored as one or more instructionson a processor-readable or computer-readable medium. The term“computer-readable medium” refers to any available medium that can beaccessed by a computer or processor. By way of example, and notlimitation, such a medium may comprise RAM, ROM, EEPROM, flash memory,CD-ROM or other optical disk storage, magnetic disk storage or othermagnetic storage devices, or any other medium that can be used to storedesired program code in the form of instructions or data structures andthat can be accessed by a computer. It should be noted that acomputer-readable medium may be tangible and non-transitory. The term“computer-program product” refers to a computing device or processor incombination with code or instructions (e.g., a “program”) that may beexecuted, processed or computed by the computing device or processor. Asused herein, the term “code” may refer to software, instructions, codeor data that is/are executable by a computing device or processor.

The various illustrative logical blocks and modules described inconnection with the embodiments disclosed herein can be implemented orperformed by a machine, such as a general purpose processor, a digitalsignal processor (DSP), an application specific integrated circuit(ASIC), a field programmable gate array (FPGA) or other programmablelogic device, discrete gate or transistor logic, discrete hardwarecomponents, or any combination thereof designed to perform the functionsdescribed herein. A general purpose processor can be a microprocessor,but in the alternative, the processor can be a controller,microcontroller, or state machine, combinations of the same, or thelike. A processor can also be implemented as a combination of computingdevices, e.g., a combination of a DSP and a microprocessor, a pluralityof microprocessors, one or more microprocessors in conjunction with aDSP core, or any other such configuration. Although described hereinprimarily with respect to digital technology, a processor may alsoinclude primarily analog components. For example, any of the signalprocessing algorithms described herein may be implemented in analogcircuitry. A computing environment can include any type of computersystem, including, but not limited to, a computer system based on amicroprocessor, a mainframe computer, a digital signal processor, aportable computing device, a personal organizer, a device controller,and a computational engine within an appliance, to name a few.

The methods disclosed herein comprise one or more steps or actions forachieving the described method. The method steps and/or actions may beinterchanged with one another without departing from the scope of theclaims. In other words, unless a specific order of steps or actions isrequired for proper operation of the method that is being described, theorder and/or use of specific steps and/or actions may be modifiedwithout departing from the scope of the claims.

It should be noted that the terms “couple,” “coupling,” “coupled” orother variations of the word couple as used herein may indicate eitheran indirect connection or a direct connection. For example, if a firstcomponent is “coupled” to a second component, the first component may beeither indirectly connected to the second component or directlyconnected to the second component. As used herein, the term “plurality”denotes two or more. For example, a plurality of components indicatestwo or more components.

The term “determining” encompasses a wide variety of actions and,therefore, “determining” can include calculating, computing, processing,deriving, investigating, looking up (e.g., looking up in a table, adatabase or another data structure), ascertaining and the like. Also,“determining” can include receiving (e.g., receiving information),accessing (e.g., accessing data in a memory) and the like. Also,“determining” can include resolving, selecting, choosing, establishingand the like. The phrase “based on” does not mean “based only on,”unless expressly specified otherwise. In other words, the phrase “basedon” describes both “based only on” and “based at least on.”

The previous description of the disclosed implementations is provided toenable any person skilled in the art to make or use the presentinvention. Various modifications to these implementations will bereadily apparent to those skilled in the art, and the generic principlesdefined herein may be applied to other implementations without departingfrom the scope of the invention. Thus, the present invention is notintended to be limited to the implementations shown herein but is to beaccorded the widest scope consistent with the principles and novelfeatures disclosed herein.

1-20. (canceled)
 21. A method of testing a test surface for the presence of a hazardous contaminant, the method comprising: wiping the test surface with an absorbent material coupled to a handle to collect particles of the hazardous contaminant from the test surface; inserting the absorbent material into an open end of a fluid-tight container containing a volume of buffer solution, wherein a first portion of the fluid-tight container is shaped to receive the absorbent material and a second portion of the fluid-tight container is shaped to receive at least a portion of the handle; sealing the fluid-tight container with a cap; agitating the fluid-tight container to release at least some of the collected particles of the hazardous contaminant into the buffer solution; transferring at least a portion of the volume of the buffer solution from the fluid-tight container to an assay test strip; inserting the assay test strip into an assay reader device; and based on an output of the assay reader device, identifying that the hazardous contaminant is present on the test surface.
 22. The method of claim 21, further comprising opening a sealable orifice of the cap.
 23. The method of claim 22, wherein the at least a portion of the volume of the buffer solution is transferred through the sealable orifice.
 24. The method of claim 22, further comprising resealing the sealable orifice after transferring the at least a portion of the volume of the buffer solution.
 25. The method of claim 21, further comprising compressing an interior volume of the fluid-tight container to expel the at least portion of the buffer solution.
 26. The method of claim 21, wherein agitating the fluid-tight container comprises inverting the fluid-tight container.
 27. The method of claim 21, further comprising applying a volume of buffer solution to the test surface.
 28. A system comprising: a collection device comprising: an absorbent material coupled to a handle, the absorbent material configured to contact a test surface to collect a hazardous contaminant, and a container having a first portion shaped to receive the absorbent material and a second portion shaped to receive at least a portion of the handle, the container having a nozzle including an orifice configured to release a volume of buffer solution from the container; an assay test strip configured to receive the volume of the buffer solution released from the container, the assay test strip comprising at least one reaction zone configured to produce an optically-detectable change in appearance in the presence of the hazardous contaminant; an image sensor configured to receive light reflected from the at least one reaction zone and configured to generate signals representing an intensity of the received light; and control electronics configured to analyze the signals and determine the presence of the hazardous contaminant in the at least one reaction zone.
 29. The system of claim 28, further comprising a demarcation guide configured to specify an area of the test surface to be tested for contamination by the hazardous contaminant.
 30. The system of claim 28, wherein the control electronics are configured to determine a concentration of the hazardous contaminant based at least partly on the intensity of the signals and an area of the test surface.
 31. The system of claim 28, wherein the assay test strip comprises: a sample receiving zone for receiving the volume of the buffer solution released through the orifice of the nozzle; and a length of material extending between the sample receiving zone and the at least one reaction zone and configured to wick at least the received buffer solution from the sample receiving zone to the at least one reaction zone.
 32. The system of claim 28, wherein at least a portion of the container is flexible such that an interior volume of the container can be compressed to expel the volume of the buffer solution from the interior volume through the orifice of the nozzle.
 33. The system of claim 28, further comprising a network connection interface, and wherein the control electronics are configured to send data representing whether the hazardous contaminant is present in the at least one reaction zone to at least one remote computing device over a network via the network interface.
 34. The system of claim 28, wherein at least a portion the absorbent material is wrapped around one or more sides of the handle.
 35. The system of claim 28, wherein the absorbent material is mechanically fastened to the handle.
 36. The system of claim 28, wherein the absorbent material is adhered to the handle.
 37. The system of claim 28, wherein the container comprises: an open end having an aperture into the interior volume; and a releasable portion of the container including: an attachment mechanism configured to releasably couple to the container over the open end to provide a fluid-tight seal with the interior volume of the container with the handle and the absorbent material and the buffer solution sealed within the interior volume, the nozzle, and a cap releasably coupled to the nozzle.
 38. The system of claim 28, wherein the length of the handle exceeds a width of the handle.
 39. The system of claim 38, wherein the width of the absorbent material exceeds the width of the handle.
 40. The system of claim 28, wherein the absorbent material extends generally perpendicular to at least a portion of the handle. 